QA Operations Specialist
Ref#: CH-FER-0094 / R0003769
- Ensure GMP compliance for production activities
- Production batch review in order to assess the quality of the batch (perform random check at the lines during production activities)
- Change status of component if appropriate to ensure GMP rules. Reject boxes or batches when appropriate
- Manage, evaluate deviations on batch product, and drive investigations plan and corrective action. Decide about batches affected by deviation when appropriate
- Ensure GMP compliance, especially during reprocessing activities. Approve relevant protocol prior execution
- Handle finished product drug complaints related to defect linked to the packaging process
- Write APR (Annual Product Review) / PQR (Product Quality Review) according to annual Master plan defined
- Follow up CAPA and change control for production activities
- Ensure feasibility of current SOP for QA operations activities and update as appropriate timeline
- Ensure validity of equipment used for production activities based on qualification status defined
- Approval of master batch records, master data and packaging instructions
- To support health inspection and customer audits
- Scientific background
- Experience in the pharmaceutical industry
- Experience in QA department
- Good communication in French and English
- Strong understanding of cGMPs and good knowledge in Regulatory requirements
- Good communication and interpersonal skills
- Problem solving mindset
- Team spirit, flexible, customer and result-oriented
- Ability to take decisions and work independently
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Serendi is a recruitment service provider with its headquarters in Switzerland. Our clients are large Swiss or international companies.
We manage the entire recruitment process for our client companies - including sourcing of candidates. Candidates are selected based on how well their experience and qualifications match our clients position requirements.
We source and screen thousands of candidates and applications per year and recommend the most qualified candidates to our clients.
If you want to apply for one of the open positions with one of our clients you can do this through this website. Please enter the required data and upload your CV. Our recruitment consultants will screen your application very thoroughly. You will receive via email constant updates on the status of your application. Please apply for each position you are interested in.