QA Operations Specialist
Bracco Suisse SABracco Suisse SA based in Geneva (Switzerland) is a company of the international Bracco Group (www.bracco.com), a leader in contrast agents for medical imaging. Our Manufacturing Site based in Geneva is approved and inspected by the most important Regulatory Agencies (FDA, Swissmedic, etc.) and produce a lyophilized contrast agent exported in several countries.For our manufacturing site based in Geneva (Switzerland) we are looking for a:
QA Operations Specialist
Job mission
To support Quality Assurance Operations activities at the Geneva Manufacturing Site. The role involves ensuring that operations are performed in compliance with current pharmaceutical GMP requirements (EU and US) as well as with the BRACCO Corporate Quality and HSE Management System.
Under the responsibility of the Quality Assurance Operations Manager, you will have to perform the following tasks:
Activities
Batch record review
- Review production batch records
- Release incoming consumables
- Review packaging batch records
Improve, maintain and ensure a continuous improvement of the following local Quality Systems to ensure the quality of the product:
- Ensure that activities related to the sterile production quality are conform with the company policies and Corporate Quality directives. Main contact in case of sterile production deviation,
- Lead and manage deviations, including those related to production, maintenance, packaging, and laboratory activities, by driving and coordinating investigations in collaboration with the relevant functions,
- Define, implement, and follow up on corrective and preventive actions (CAPA) within the scope of responsibility, ensuring timely execution and effectiveness in line with defined deadlines,
- Manage complaints investigation,
- Participate to the review and approval of the validation/qualification documentation related to sterile production area,
- Ensure the creation, review, and timely update of QA Operations documents,
- Review/approve for issuance of GMP documents related to production area (SOP’s, specifications protocols, reports..),
- Participate in and/or lead risk analyses, in collaboration with cross-functional teams,
- Participate to change control process,
- Auditor in self-inspections and external audits (lead auditor if qualified),
- Support external audit, notified Bodies and Regulatory Authorities,
- Audit trail review of GMP systems.
- Training for classified area
Communication
- Evaluate any signal detection that may have a potential impact on product quality.
- Promptly report any Quality Alert or issue to the Operations Quality Manager and the Quality Unit Manager and actively contribute to the resolution of significant quality issues.
Ensure effective communication and collaboration with Sterile Production, Maintenance, Packaging, and other relevant functions to support product quality throughout its lifecycle.Management
- Indirect management of investigation teams.
Qualifications & Skills
- University degree in Pharmacy, Chemistry or Biochemistry
- Over 5 years in Quality Management in Pharmaceutical Industry
- Solid knowledge of cGMP, including Annex 1
- Experience in lyophilized products and aseptic process
- Indirect Management in project or investigation
- Quality commitment, flexibility, initiative and problem-solving skills.
- Team working; cross functional cooperation behavior.
- Fluency in French and English (both oral and written)
- Excellent team player with a strong ability to communicate.
We offer
- The opportunity to join a well-established and successful company with bright prospects and state-of-the-art manufacturing sites and production facilities
- A great development perspective and the opportunity to bring and utilize your know-how and expertise
- Competitive remuneration packages as well as first class benefits complete this offer
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