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Hobson Prior are recruiting for a QA Consultant to join an international healthcare organisation who are focused on offering medical solutions in order to transform patients' lives. This position will be responsible for quality assurance involved primarily with the review of bulk or packaged commercial drug products, raw material batches if required, and maintaining working relationships with QA departments at contract facilities.
- You will support the design of Master Batch Records for bulk or packaged commercial drug products.
- Accountable for the review "on the floor" (if applicable) of executed batch records and associated QA samples (API, raw materials, bulk, semi-finished and finished products).
- Handles deviations, CAPA, and Change Control related to the client and to ensure the execution and the follow up of escalation processes up to both the client local and global level.
- Handles in cooperation with partners for GMP activities.
- Writes new, revises and makes recommendations for SOP and quality documents for Quality department and supported departments of Couvet manufacturing site.
- Handles qualification and validation documentation for QA review of relevant documents / reports (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) and supports execution.
- Supports in cooperation with Corporate Quality the approval and qualification of suppliers of bulk drug products, quality control laboratories, packaging services and packaging materials including participation to auditing and establishing Technical/Quality Agreements.
- Supports in collaboration with the client, the approval of GMP.
- Material suppliers for the client's production site and ensures periodic evaluation of GMP Material Suppliers as required in collaboration with the clients GMP/GDP audit function.
- Supports the internal GMP-audits process including the yearly internal audit plans, the writing of audits reports (paper or electronically) and the follow up and the implementation of the internal audit CAPAs.
- Any other assigned tasks.
- Strong written & oral communication skills in both French and English.
- Works independently, yet effectively in a team environment, makes proposals and facilitate decision when escalation is needed.
- Excellent investigational skills and QA problem solving skills.
- Ability to focus attention to details.
- Excellent interpersonal collaborative, organizational and training skills.
- A minimum of 3 years' experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
- BSc/BA or MSc in Science or relevant discipline.
- In-depth understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Good understanding of solid oral dosage form packaging and warehousing, or bulk and QC processes.
- Knowledge of most common office software.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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