Quality Assurance Specialist - Drug Product | GMP Manufacturing
Job Description
A pharmaceutical manufacturing organisation is seeking a Drug Product Quality Assurance (QA) professional to act as a QA representative within project teams and manufacturing operations. This role is responsible for representing QA in meetings, serving as a key point of contact for Drug Product–related QA topics, and ensuring GMP compliance across drug product manufacturing activities.
In this position, you will act as the QA interface for deviations and change requests, support and approve risk and gap assessments, and review and release product‑specific documentation. You will represent Drug Product QA during regulatory inspections, support continuous improvement initiatives, and work closely with Manufacturing, QC, Support Functions, Project and Site Engineering, and technology transfer teams to ensure effective execution of Drug Product processes.
Qualifications
* University degree or equivalent in Chemistry, Biology, Biotechnology, or a related field
* Long‑term experience working in a GMP environment within the pharmaceutical industry
* Experience working in a Drug Product Quality Assurance department
* Ability to act as QA representative in project teams and cross‑functional meetings
* Experience reviewing, assessing, and approving GMP quality records, including deviations, change controls, CAPAs, investigations, effectiveness checks, extensions, complaints, and APRs/PQRs, in line with local SOPs
* Experience reviewing and releasing product‑specific documentation such as process descriptions, workflows, recipes, manufacturing protocols, transfer documents, test plans, and parameter lists
* Experience supporting and approving risk assessments and regulatory‑specific risk or gap assessments
* Experience representing Drug Product QA topics during regulatory inspections
* English language skills are required
Preferred Requirements
* German language skills are an advantage
Practicalities
Start Date: ASAP
Scope: Drug Product Quality Assurance support within GMP manufacturing operations
Interested?
Send your CV to Miguel Gomes at m.gomes@panda-int.com or call +31 (0)20 2044 502 / +41 (0)44 5514 407 to discuss the opportunity.
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