Senior Quality Assurance Specialist - Systems (m/f/d)

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.

The role involves responsibility for relevant sections of the Quality Management System (QMS) to implement and execute tasks relating to day-to-day Quality Assurance (QA) aspects,but also executing those tasks him/herself. The role entails taking responsibility for QA matters around processes and documentation and for the QA team under their responsibility and supervision.

Responsibility:

Oversight of assigned Quality Management System areas that would also include but not be limited to:

• Lead, support, develop and mentor QA team members under their direct supervision.

• Leads development and maintenance of QMS documents and eDMS.

• Leads in the execution of training for quality & other relevant personnel.

• Implementation of the defined quality objectives for their QMS areas.

• Control and further development of the QMS areas under their oversight.

• Distribution, structuring and monitoring of quality tasks associated to QMS areas.

• Assist in the execution of tasks related to the daily aspects of QA department and QMS.

• Participation in customer meetings to discuss metrics or QMS aspects.

• Coordinates and assists with internal GMP audits.

• Assists in the performance of external audits (e.g vendors, 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.

• Supports relevant aspects of the QMS associated with management of changes, investigations, deviations, root cause analysis, CAPAs, risk assessments, qualification/validation, recalls and quality metrics as required by the business.

• Undertakes and supports quality related tasks associated with strategic projects.

Requirements:

• 5 Years’ Experience within a quality systems related role (ideally pharma related) required.

• 2 to 3 years experience of leading teams/people with experience in disciplinary processes required.

• Demonstrable experience within Quality department, ideally in a packaging or pharmaceutical company or comparable required.

• EU GMP framework knowledge required.

• Knowledge of packaging equipment, facilities and processes preferred.

• Training and Documentation management experience preferred.

• Fluent in business English and German required.

• Good Interpersonal skills

• Good written communication skills

• Good team skills

• Analytical approach / attention to detail

• Self-motivated and organised

• Persuasive negotiating skills

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, Equity and Inclusion 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.