Specialist QA Compliance & BRO - Switzerland
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Posted on : 08 March 2017
- This position is responsible for quality assurance (QA) involved primarily with the review of bulk and packaged commercial drug products, API batches if required, and maintaining working relationships with QA departments at contract facilities.
- The position will support QA activities (deviation, CAPA, OOS, change control, risk management, audit, inspections...) on the International II Sàrl manufacturing site.
- As a key member of the Quality Operations team, this position will be expected to be a reliable source of information and interpretation of quality and cGMP compliance requirements
- For the project phase of the plant, the position holder, jointly with the QA team, will support the project team as Quality Operations interface responsible of all GMP topics (regulations, quality systems, training) and further support the development of the team to sustain the start-up, licensure, and commercial phases.
Qualifications Skills/Knowledge Required
- At least 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
- BSc/BA (or equivalent) in Life Sciences or a related discipline.
- Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Solid understanding of solid oral dosage form manufacturing/packaging processes and QC testing methods.
- Works independently, yet effectively in a team environment.
- Excellent investigational skills and QA problem solving skills, has a keen eye for Quality.
- Excellent written & oral communication skills in both French and English.
- Good interpersonal and training skills.
- Ability to focus attention to details.
- Knowledge of most common office software