QA Compliance Specialist - Switzerland
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- QA Compliance is committed to actively support company International manufacturing site and other departments to ensure cGMP compliant processes on the company manufacturing site.
- This position is responsible for quality assurance (QA) involved primarily with the support of the different quality system tools in place to ensure cGMP compliance throughout the manufacturing site. The position holder will be responsible for the assigned processes and activities within QA Compliance and will act as member of the Quality Surveillance team.
- The activities include responsibility for execution of the main following processes: internal audits, annual product review reporting and suppliers qualification.
- Additional tasks are the support of health authorities inspections and corporate audits, monitoring of regulatory changes, response to regulatory authorities requests, QA oversight on contract manufacturing / testing partners, deployment and execution of annual GMP training and reporting of quality processes
- metrics.. The QA Compliance Specialist can be assigned special tasks in cross-functional projects to support manufacturing site activities like introduction of new product on the manufacturing site.
- As a member of the Quality Operations department, this position will be working closely with the QA Compliance management to identify and handle process quality and cGMP compliance related issues.
- Supports internal audits plan by executing self inspections and following-up on action plans.
- Supports the supplier qualification process by assisting in material supplier and vendor evaluation and approval. The position holder may participate in external audits as company
- audit team member, QA liaison or subject matter expert (SME).
- Provides support for vendor and supplier contract setup and modification, as needed. Is responsible to handle deviations, change controls related to suppliers.
- Generates annual product reports for products made on manufacturing site.
- Supports preparation and execution of authorities inspections and corporate audits in different roles (i.e. back office, subject matter expert, note taker or runner).
- Performs QA oversight of assigned contract manufacturing / testing partners as assigned.
- Informs on regulatory changes and coordinate assessment and action plans with SMEs.
- Provides response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review.
- Supports the deployment and execution of GMP training intended for all manufacturing site departments involving GMP activities.
- Contributes of regular reporting of quality processes metrics for different review meetings.
- Ensures the representation of QA within department and cross-functional project teams according to assignments.
- Assists with writing SOPs and makes recommendations for SOP revisions for the Quality Operations and supported departments of manufacturing site.
- Acts as deputy for colleagues within QA Compliance team.
- Can be assigned “ownership” of QA Compliance processes, including coordination of day to day activity, maintenance of associated documentation, participation of process enhancement and training of new users.
- At least 3 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance.
- BS in Science or related field.
- Very good understanding of cGMPs and regulatory requirements.
- Good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred.
- Excellent interpersonal, collaborative and organizational skills.
- Works independently on routine tasks, makes decisions for minor issues.
- Ability to focus attention to details.
- Very good written & oral communication skills.
- Very good investigational and QA problem solving skills.
- Knowledge of most common office software (Microsoft Office).