QA Specialist

Responsibilities

• Create, review, and approve Standard Operating Procedures (SOPs) and GMP documentation in accordance with regulatory standards.
• Manage and review quality events, including deviations, change controls, non-conformities, CAPAs, and Out of Specification (OOS) results.
• Participate in root cause investigations and approve implementation plans.
• Support internal and external quality audits, including client audits and health authority inspections.
• Review and approve analytical validation protocols, methods, specifications, and reports.
• Oversee the review and approval of analytical packages, including stability data, cleaning samples, and in-process controls.
• Manage the release of starting materials following analytical review and verify finished product shipments.
• Ensure data integrity and traceability throughout the production and laboratory processes.

Requirements

• University degree in Biotechnology, Chemistry, or Pharmacy.
• English proficiency at a B2 or C1 level (essential for defending processes during client or regulatory audits).
• Hands-on experience with analytical techniques, specifically HPLC (fundamental), Spectrophotometry, ELISA, KF, or Dissolution.
• Practical knowledge of quality event management, including OOS, Change Control, Deviations, and CAPAs.
• Strong documentation skills and attention to detail.
• Proactive mindset with a results-oriented approach and ability to work effectively in a team.

Preferred Qualifications

• Previous experience participating in formal quality audits.
• Strong critical thinking skills within a laboratory or manufacturing environment.

Benefits

• Competitive salary.
• Health insurance and medication reimbursement.
• English language classes.
• Discounts on various activities and gym collaborations.
• Employee referral program.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We focus on quality and operational excellence, fostering an inclusive culture where talented individuals can grow their careers through intentional learning and real-life experience.