Quality Assurance Specialist
5 giorni fa
Key Responsibilities:
- We are seeking a Qualified Person to guarantee and certify that each batch of medicines is produced and checked in compliance with the law and marketing authorization conditions.
- The ideal candidate will assess and release manufactured medicinal products, ensuring compliance with national legislation.
- You will guarantee that documentation attesting product lot suitability is available and can be presented upon request by health authorities.
- Collaborate with departments to approve deviation investigations and ensure batch records are stored correctly.
- Communicate immediately to national Health Authorities and management any substantial irregularities detected in products already on the market.
- Work closely with Quality Control and Production departments to ensure manufactured batches meet quality standards.
- Identify and propose interventions to improve manufacturing processes in terms of quality, productivity, and costs.
- Collaborate with Function Managers to ensure the correctness of the Quality Management System.
- Manage deviations, complaints, change control, and CAPA.
Requirements:
- Degree in Pharmacy, CTF, or Chemistry.
- Previous experience as a Qualified Person in a pharmaceutical manufacturing environment with an Authorized Qualified Person certificate.
- Strong affinity for quality and awareness of quality issues.
- Excellent communication and collaboration skills to ensure daily production operations run smoothly and safely.
- Fluent in English.
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