Lead Qualified Person
vor 3 Monaten
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 PCI Berlin Qualified Person (QP) batch release team to implement and execute tasks relating to day-to-day QP aspects, also executing those tasks him/herself as the business demands. The role entails taking responsibility to ensure that our QP batch review teams and processes are compliant to GMP regulations, guidelines (including German law) and that we review and release products within a timely manner for our customers.
Main responsibilities:
Oversight of assigned QP batch release team would include but not be limited to:
- Lead, support, develop and mentor QP/QA batch release team members under their direct supervision.
- Implementation of defined quality goals and objectives for the batch release team, process and associated areas.
- Distribution, structuring and monitoring of QP tasks associated with the batch release function to ensure the team is performing QP certification tasks in compliance with the Quality System (including site LAVG licenses), EU GMP, Product Specification File and Clinical Trial Application (CTA/IMPD).
- Directly assists in the execution and completion of QP tasks related to the batch release function, as the business demands.
- Participation in customer meetings to discuss batch release processes or other relevant Quality tasks and functions.
- Coordinates and assists with GMP internal audits.
- Coordinates and assists in the performance of external audits (e.g vendors, customer supply chain sites as required).
- Supports and assists with customer and regulatory audits and actions as required.
- Hosts/attends cross-departmental meetings as required acting as the quality representative for batch release.
- Control and further development of the quality system areas under their oversight.
- Supports tasks within wider quality system or business areas as required.
- Supports in the execution of relevant training for quality & other relevant personnel.
- To keep up to date with the GxP requirements of the LAVG, EMA and rest of world (where relevant) regulatory agencies as they impact upon PCI Berlin processes.
- Undertakes and supports quality related tasks associated with strategic projects.
Qualifications and experience:
- Qualified Pharmacist that is eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives and guidelines.
- Greater than 5 Years’ pharmaceutical experience within a quality systems related role with QP batch review and release experience.
- Ideally experience of leading teams/people with experience in managing performance.
- Ideally experience of working within a pharmaceutical packaging and distribution facility with experience in managing activities associated with clinical trial supplies.
- Detailed knowledge of Quality Systems and experienced in hosting regulatory audits.
- Fluent in business English and German
- Good Interpersonal skills, Written Communication, Numeracy / Literacy
- Technical aptitude
- Strong commitment to Quality Assurance principles
- Analytical approach / attention to detail
- Professional
- Self-motivated and organised
- Persuasive
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._
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