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

　　Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

　　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.

　　Why work for PCI Pharma Services?

　　At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

　　PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled