Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main purpose of job:
Leading the Quality Control department. Ensure that products are delivered on time and in the required quality. On-time and high-quality delivery of test documents and samples to customers. Contribute to the continuous improvement of customer and employee satisfaction, in particular through continuous improvements with regard to our quality objectives. Promoting cross-departmental and cross-sector communication, particularly with regard to cross-divisional processes.
Authority to issue instructions regarding GMP aspects to all employees in his/her area of responsibility. This does not include disciplinary authority, which is regulated in the organizational structure.
Status changes of materials and orders that do not meet the requirements. In the case of medicinal products, only internal release for packaging and storage is possible; release to the customer is carried out by the Qualified Person.

Main responsibilities:

• Management and leadership of the Quality Control team
• Control of goods to be dispatched.
• Participate in the control of incoming goods.
• Batch Record control during production.
• Control of maintenance, facilities and equipment for the performance of tests.
• Monitor and control of environmental temperatures during the manufacture and storage of all materials and pharmaceuticals used.
• Participate in creation, updating and review of SOP’s related to quality control.
• Supervise personnel and factory hygiene within the department.
• Assume other tasks as directed by supervisor after relevant training.
• Create, update and review of SOP’s related to quality control.
• Approval or, if he deems it necessary, rejection of raw materials, packaging material, intermediate products, bulk goods and finished goods/
• Release of finished goods in the system
• Implementing and observing the management system (ASI, QM, UM, - FSC etc.), in particular the rules of Good Manufacturing Practice (GMP).
• Ensuring that all agreed tests have been carried out and the associated protocols have been evaluated
• Batch record review before forwarding to QP (for medicinal products)
• Continuous training of employees in their area
• Assessment of deviations (internal and external complaints).
• Deciding on the further treatment of defective products. Further processing of faulty products must be monitored until the fault or unsatisfactory condition has been rectified.
• Assisting in the monitoring and control of ambient temperatures during the manufacture and storage of all materials and medicinal products used. If necessary, coordinating measures together with the production manager.
• Approval of specifications, instructions for sampling of test instructions in accordance with § 14 para. 1 and ensuring that these are complied with.
• Specification:
• At least 5 Years’ Experience within a quality systems related role, preferably as a manger
• Demonstrable experience within Quality department in a packaging or pharmaceutical company.
• High level knowledge of packaging equipment, facilities, and processes.
• To have good knowledge of Quality Assurance inspection requirements.
• Good working knowledge of cGMP
• QMS Experience
• Risk Analysis and Associated Methodology
• Knowledge of ICH, GAMPs, Annex 11 and Eurdalex guidelines
• Formally qualified to Degree level in an Engineering or other scientific discipline
• Received formal training in cGMP requirements from Quality Assurance
• Fluent in business German and English
• Very good team and leadership skills

Benefits for you:

• BVG Jobticket
• LinkedIn Learning
• Germand and English Language classes
• Fruit baskets
• Cake Day
• Employee Referral Program
• Volunteering activities with the ESG Social Committee

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Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status

• Management and leadership of the Quality Control team
• Control of goods to be dispatched.
• Participate in the control of incoming goods.
• Batch Record control during production.
• Control of maintenance, facilities and equipment for the performance of tests.
• Monitor and control of environmental temperatures during the manufacture and storage of all materials and pharmaceuticals used.
• Participate in creation, updating and review of SOP’s related to quality control.
• Supervise personnel and factory hygiene within the department.
• Assume other tasks as directed by supervisor after relevant training.
• Create, update and review of SOP’s related to quality control.
• Approval or, if he deems it necessary, rejection of raw materials, packaging material, intermediate products, bulk goods and finished goods/
• Release of finished goods in the system
• Implementing and observing the management system (ASI, QM, UM, - FSC etc.), in particular the rules of Good Manufacturing Practice (GMP).
• Ensuring that all agreed tests have been carried out and the associated protocols have been evaluated
• Batch record review before forwarding to QP (for medicinal products)
• Continuous training of employees in their area
• Assessment of deviations (internal and external complaints).
• Deciding on the further treatment of defective products. Further processing of faulty products must be monitored until the fault or unsatisfactory condition has been rectified.
• Assisting in the monitoring and control of ambient temperatures during the manufacture and storage of all materials and medicinal products used. If necessary, coordinating measures together with the production manager.
• Approval of specifications, instructions for sampling of test instructions in accordance with § 14 para. 1 and ensuring that these are complied with.
• Specification:
• At least 5 Years’ Experience within a quality systems related role, preferably as a manger
• Demonstrable experience within Quality department in a packaging or pharmaceutical company.
• High level knowledge of packaging equipment, facilities, and processes.
• To have good knowledge of Quality Assurance inspection requirements.
• Good working knowledge of cGMP
• QMS Experience
• Risk Analysis and Associated Methodology
• Knowledge of ICH, GAMPs, Annex 11 and Eurdalex guidelines
• Formally qualified to Degree level in an Engineering or other scientific discipline
• Received formal training in cGMP requirements from Quality Assurance
• Fluent in business German and English
• Very good team and leadership skill