Qualified Person

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:
The role is to implement and execute tasks relating to QP duties and certification activities associated with manufacturing processes/activities performed under PCI Pharma Services Germany GmbH (PCI) licences.

Main responsibilities:

- Maintain compliance with GMP and customer expectations as defined in Quality Agreements, LAVG/German legal framework, LAVG licences and EU GMP Directives/Guidelines.
- Review Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorisation.
- Certify Medicinal Products for use in the EU and outside the EU (acc. to Annex 16).
- Undertake audits in EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
- Review PCI Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PCI procedures.
- Provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.
- Assistance with regulatory inspections and client audits.
- Identify and support opportunities for improving internal processes and or procedures
- Support training needs across the site for Commercial and Clinical Activities.

Experience:

- Experienced in QP certification activities associated with investigational and commercial medicinal products.
- Experienced in sterile dosage forms.
- Experienced in non-sterile dosage forms.
- Experienced in large molecule biopharmaceuticals.
- Experienced in EU GMP audits (QP audits) of third country manufacturing and testing facilities.
- To have demonstrable experience of packaging and processing activities within the pharmaceutical industry.
- Experienced in working across multiple facilities as part of a global organisation.

Knowledge:

- High level knowledge of GxPs across the pharmaceutical industry for both investigational and commercial medicinal products.
- To have good knowledge of Quality Management Systems and principles.
- Continuous Improvement methodology.
- Risk Analysis principles and associated methodology.
- Qualifications and Training.
- Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with both EU directives (2001/83/EC and 2001/20/EC) and local LAVG/German legal requirements.
- Educated to Pharmacist degree level.

Skills & Aptitude:

- Fluent in German and English to business level (read, write and verbal)
- Good interpersonal skills, ability to interact with cross-functional teams and internal/external stakeholders
- Ability to prioritise work and handle competing business needs.
- Good written communication skills.
- Good teamworking skills with ability to direct and influence team members.
- Ability to develop team members through coaching, mentoring and training of staff as required.

LI-JP1

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._
- At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._