Carieră STADA România

Qualifications

• Quality performance and accomplishment of all tasks in the scope of the Packaging Materials testing process.
• Bachelor’s degree in pharmaceutical, chemical or technological sciences (Faculty of Pharmacy, Faculty of Sciences and Mathematics – Department of Chemistry or Physical-Chemistry)
• 3 years’ work experience in similar field.
• Detail oriented, with strong time management skills and the ability to work on multiple simultaneous projects.
• Efficiency, meeting the deadlines and improving the work.
• Very good analytical and organizational skills, result oriented.
• Adequate use of capacities and efficient and cost-effective use of resources
• Self-motivated, able to work under minimal supervision and to provide a calm environment during times of uncertainty.
• Proactive, with excellent interpersonal, communication skills.

Specific responsibilities:

• Performing analyses on packaging materials according to approved analytical methods/procedures/validation protocols/method transfer protocols.
• Recording, review and report of tests results performed for packaging materials.
• Involvement in the investigations related to the deviations, OOX or any other non-conformities related to the packaging material results.
• Involvement in the issuance process of the department documentation (operating procedures, working instructions).
• Handling the samples and GMP documentation properly and in accordance with all in-house documents and procedures, related to their safe receipt, placement, storage, keeping of all written and electronic records, issuance and delivery for disposal and destruction thereof, test results and quality of work.
• Communicating with other relevant units within and out of quality control.
• Actively participating in meetings within and out of quality control and participating in resolving of relevant problems.
• Responsible for the high-quality performance and accomplishment of entrusted tasks.
• Performing other assigned duties by the manager of quality control.

Qualifications:

• University degree in Supply Chain, Economics/Finance, or similar.
• Supply/Production Planner experience in Pharma or batch production environments.
• APICS/ASCM CPIM and CSCP accreditations preferred.
• Experience with SAP MPS, MRP, and APO SNP/PP/DS.
• Knowledge of end-to-end manufacturing site supply chain processes.
• Demonstrated ability to lead and collaborate in a manufacturing environment.
• Working knowledge of logistics related to delivery terms, customs procedures, and transportation.
• Change management and process management experience.
• Demonstrated usage of data to drive process improvements.

The Supply Network Planner is responsible for defining the Supply Plan for products which are manufactured and/or packed within the site/cluster. Accordingly, they work on providing all the necessary conditions to secure that the planning process runs smoothly.   

Responsibilities:

Supply Planning:

• Perform supply planning in regular monthly and weekly cycles within operational and tactical planning horizons.
• Analyze forecast changes and adjust supply planning accordingly on a regular monthly cycle.
• Communicate changes to affiliates/sales and marketing for better market understanding.

Collaboration and Coordination:

• Ensure alignment with all functions involved in the planning process, including Demand Planning, L&T coordination, Production Planning, and Purchasing.
• Collaborate with the Supply Planner in the Rough-Cut Capacity Planning process.

Monitoring and Reporting:

• Analyze changes in the S&OP planning horizon for the monthly planning cycle.
• Communicate the supply plan to the Production Planner and regularly check the supply situation in the weekly planning cycle.
• Report weekly stock-outs and overstock as part of the global S&OE process.

Risk Management and Compliance:

• Escalate supply risks to predefined functions and throughout the supply chain to find solutions.
• Perform allocation of available resources based on prioritization rules in case of constraints.
• Ensure compliance with GMP and regulatory requirements.

Customer Service and KPIs:

• Act as a single point of contact for affiliates, providing intercompany customer service.
• Maintain master data according to predefined policy.
• Analyze site/cluster KPIs regularly.

Qualifications
Education:
• Higher education in a technical field.
• HSE course, minimum 80h (240h is a plus).
Professional Experience:
• 3 years expertise in a manufacturing environment: pharmaceutical industry (is a plus), FMCG, food, automotive or similar fully regulated businesses;
• Experience with iso 14001 and iso 45001 standards is a plus
• Proficient in using Microsoft suite: (outlook, excel, PowerPoint, word, teams, SharePoint, etc.)
• Previous project implementations represent an advantage
Competencies:
• A professional individual, detail oriented, with strong time management skills and the ability to work on multiple simultaneous projects.
• Very good analytical and organizational skills, result oriented.
• Good communication skills with authorities, team members, external providers, and management.
• Self-motivated, able to work under minimal supervision and to provide a calm environment during times of uncertainty.

This position will ensure compliance with the legal and company requirements regarding Health and Safety for the Turda plant.

Responsibilities:

• Prepare the documentation in the field of Health and Safety required by Romanian legislation for the new STADA plant in Turda (risk assessments, protection and prevention plan, training schedule, training materials, specific Health and Safety instructions and procedures, etc)
• Conduct trainings required by Romanian legislation and by STADA to increase Health and Safety culture and awareness within STADA Turda.
• Organize the Health and Safety committee (CSSM)
• Organize internal authorization sessions for electricians
• Organize the first aid program (training, materials, practical exercises)
• Drive / contribute to incident investigations, identify root causes, set corrective and preventive actions and track their completion
• Prepare reports required by Romanian legislation and by STADA in the field of Health and Safety
• Maintain communication with the competent authorities and other collaborators as needed.
• Maintain relationship with analysis laboratories to perform exposure measurements and monitoring, as needed.
• Develop, implement and maintain Health and Safety procedures in accordance with legal and company requirements.
• Conduct inspections, planned or ad-hoc, prepare reports, communicate the findings, set corrective and preventive actions and follow up on implementation.
• Manage all aspects related to Health and Safety for the site
• Propose and drive implementation of Health and Safety improvement projects.
• Ability to assure back-up for Environment and Emergency preparedness (Mediu & SU) activities is a plus.

Qualifications:
• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field
• Proven experience in stability testing within a pharmaceutical or packaging environment
• Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• Strong knowledge of regulatory requirements related to stability testing
• Detail-oriented with excellent analytical and problem-solving skills

Responsibilities:
• Compile and review stability protocols
• Establish annual plans for on-going stability studies and setting sampling points
• Monitor stability studies, review obtained results and compile related reports
• Maintain accurate and up-to-date documentation to support regulatory submissions
• Ensure that all stability testing activities and documentation comply with regulatory requirements, industry standards, and Good Manufacturing Practices (GMP), pharmacopeias
• Investigate and address any stability-related issues or deviations, proposing corrective actions to maintain product quality.
• Compile and review stability sections in Product Quality Reviews
• Compile and review document related to site-to-site technology transfers
• Prepare and review operating procedures, working instruction, user’s requirement specifications for equipment
• Participate in qualification and requalification activities for equipment and used software
• Identify opportunities to improve stability testing processes and procedures
• Implement best practices and stay updated with industry trends and advancements
• Support constant improvement initiatives, implementation of new technologies and learning culture
• Cooperate with cross functional teams within the group to ensure product stability and quality

Specific attributions:
1. Performing physico-chemical tests in the drug control laboratory using different analysis techniques such as: high-pressure liquid chromatography, gas chromatography, mass spectrometry, UV-VIS spectrometry, potentiometry, IR spectroscopy;
2. Processing the results obtained after performing various tests;
3. Reporting the results obtained;
4. Compliance with existing work procedures at department and company level;
5. Respect the documentation that accompanies the product for inspection;
6. Use the materials and equipment correctly and in accordance with the approved documentation;
7. Prepares the work instructions for the techniques he performs as the responsible person.

Responsibilities and duties in the field of Quality Assurance, Good Manufacturing Practice Rules, Analytical Laboratory Good Practice Rules

1. Knows and respects Standard Operating Procedures, Work Instructions, internal notes;
2. Responsible for the efficiency and quality of the activity in the laboratory based on the knowledge of the documents of the Quality Assurance System created and implemented in the laboratory;
3. Participates in internal and external training programs in the field of BPF, BPLA;
4. Participate in the preparation and updating of the Quality System documents.

Requirements:
1. Higher education – graduates of the Faculty of Pharmacy or Chemistry;
2. Elementary notions of arithmetic and chemistry;
3. Knowledge of the English language. medium level;
4. Knowledge of computer operation (Word, Excel, Internet, Outlook);
5. Responsible person, organized, attentive to details;
6. Excellent working skills both individually and in a team;
7. Experience in the field is an advantage;

Abilities:
1. Attention to details;
2. Responsible, organized person;
3. Excellent working skills both individually and in a team;

Short description of the desired candidate:
We are searching for a candidate who has good coordination and project management skills and even stronger supply chain expertise. They should have supply chain background with planning expertise and project management skills.
The candidate we are searching for is preferred to have entrepreneurial spirit which will support in the start-up environment we will be working in for the upcoming period. In change of their effort the candidate will also be part of a team who is eager to arise a new pharmaceutical packaging site in the country.

Your qualification:

Soft Skills:
• Excellent communicator who is able to drive multiple projects in parallel on a global and multi-functional level
• Embraces empowerment and have strong influencing skills as well as ability to achieve results in a collaborative way.
• Team player with the ability to support ideas and make change happen
• Reliable, independent and high degree of involvement required
• Fluent in English, other languages desirable

Professional:
• Degree in business, economics or pharmacy (or a discipline relevant to the role)
• Is able to think, act and initiate in operational, tactical and strategic terms.
• Has to be familiar with the current regulations in the pharmaceutical industry.
• Strong abilities in project and process management

Your responsibilities will include:

• Coordination and management of product transfers of STADA AG in the regions EU, CIS, SEE and Emerging markets
• Ensuring adequate information flow and coordination between all internal and external stakeholders
• Ensure oversight of supply chain changes and lead end-to-end change control management, working in a cross-functional environment
• Communicate and inform all stakeholders such as planning, production, quality and regulatory as well as suppliers and affiliates along the process
• Guarantee transparent information exchange and overall project timelines
• Monitor production, delivery and release steps along the supply chain
• Support transfer decisions and set up business cases
• Identification of risks and work out scenarios to enable a successful implementation of transfers
• Focus on material impact related to timelines and costs
• Assist in the development of improved processes
Organizational aspects:

• Role may have a hybrid work schedule, always pre-aligned with and approved by manager and according to the company policy
• The role will have a Global reporting (functional) to Global Transfer Execution Management and Operational/Legal to local Supply Chain Head. Candidate will be part of the Stada Global Transfer Execution team
• Role will focus on site start-up and transfer-in products overall process from an Transfer Execution perspective
• Role will benefit of proper training for on-boarding (Germany, Serbia) and further sustainability/continuous improvement. Periods will be pre-aligned with the candidate to match candidates schedule and company’s goals.

Master Data (MES)
Responsible for implementing the Batch Packaging Protocol side in MES project:

• Minimum 3 year expertise in manufacturing/processing environment: pharma, FMCG, food, automotive preferred
• Two year experience with computerized systems (MES = Manufacturing Execution Systems). Implementation of the systems represents an advantage.
• Good understanding (experience driven) of manufacturing processes and linkages between different production steps
• Previous, documented, project implementations represent an advantage
• Goal oriented person, keen on delivering results

Required skills:

• good understanding of hardware, software, and networking concepts, as well as experience with troubleshooting and problem-solving.
• patient, empathetic, and responsive to end-users needs, providing timely and effective solutions to their IT-related problems.
• a professional individual, detail-oriented, with strong time management skills and the ability to work on multiple simultaneous projects;
• very good analytical and organizational skills, result oriented;
• good communication skills to communicate with customers, team members, external data providers, and management;
• good personal computer and business solutions software skills;
• self-motivated, able to work under minimal supervision, and to provide a calm environment during times of uncertainty.

• Provide technical assistance and support to end-users, responding to inquiries and troubleshooting issues related to hardware, software, network connectivity, and other IT-related problems.
• Maintain and update documentation of technical support procedures, including frequently asked questions (FAQs), troubleshooting steps, and solutions to common problems.
• Escalate issues to appropriate teams when necessary, ensuring timely resolution and minimal disruption to end-users workflow.
• Monitor and maintain IT systems, networks, and infrastructure
• Participate in the development and implementation of IT policies and procedures
• Conduct system audits and identify areas for improvement
• Assist with the implementation and maintenance of IT systems and networks, including installation, configuration, and troubleshooting of hardware and software, as well as monitoring and performance tuning to ensure optimal performance and reliability.

• managing and monitoring critical business projects implementation, focused on improving flexibility, productivity and quality with using Lean Manufacturing and Six Sigma tools to optimize the business;
• planning and coordinating continuous activities based on Lean methodology to reduce costs;
• lean Six Sigma culture promotion through delivering needed knowledge and tools, trainings and mentoring;
• leading COGS initiatives to drive improved financial performance;
• identifying possibilities to improve business processes in collaboration with managers and all functional teams, preparation and implementation strategic plans for continuous improvements in cooperation with local, regional and global TechOps management;
• ensure integration with local and regional programs;
• monitoring and reporting KPI and status of strategic projects implementation (connected with CI);
• identification of project addressing site priorities and proposing, together with HR Department, candidates for Green and Black Belts certification achieved with implementation of defined projects;
• implementing best practices and coordination of experts participation in best practices network meetings and communication;
• implementation and improvements of Visual Management;
• supporting delivery of working methods for employees which guaranties high productivity and quality with compatibility with implemented standards;
• cooperation with global structures in terms of implemented solutions which improves business processes;
• contributes to preparation and implementation of Site Quality Plan and participates in Site Quality Council/Committee;
• facilitates continuous improvement of processes performance;
• ensure appropriate communication processes are established and implemented to allow the flow of appropriate information between departments and ensure timely and appropriate escalation to management of major and critical issues;
• ensure that the HSE procedures are adequately followed within the area of responsibility and specific Health and Safety legislation is strictly followed; HSE training delivery according with company training plan;
• ensure activities are handled in compliance to all applicable Corporate rules and regulations, including Code of Conduct;
• performs the BC Team Project Support role.

• Education: Bachelor degree in Pharmacy, Chemistry, Biology, Engineering or similar
• Languages: English fluent in speaking and writing; additional languages preferred
• Experience: Preferably with experience in the Pharmaceutical Industry and GMP environment

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