Quality Assurance Specialist

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 Quality Assurance Specialist reports to the Senior Quality Assurance Specialist and has no personnel responsibility.

The main responsibility of the role is to ensure fulfillment of the quality assurance requirements in accordance with the GMP guidelines, customer requirements and other specifications from site certifications.

Responsibilities

• Co‑ordination and review of events, deviations, nonconformances and complaints; creation of final reports.
• Co‑ordination of change controls; following up on change‑control actions with responsible owners and ensuring timely completion.
• Interdepartmental communication and problem solving in accordance with European GMP guidelines.
• Drafting, reworking and reviewing SOPs, work instructions and forms.
• Participation in the preparation of risk analyses.
• Supporting continual improvement processes, validation and qualification activities as required.
• Carrying out administrative work in the quality system, such as maintaining lists, folder structures and logbooks and preparing monthly metrics.

Qualifications

• Completed vocational training with several years of relevant experience or a Master’s degree or equivalent in the pharmaceutical, scientific or technical field.
• Good written and spoken German and/or English skills.
• Good knowledge of MS Office (Excel, Word and Outlook).
• GMP knowledge or knowledge of comparable regulations is advantageous.
• 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.

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