- Batch record review and release
- Approve/close deviations and propose CAPAs.
- Make sure cGMP are applied.
- To propose ideas for Quality System efficiencies' and effectiveness' improvement.
- To assure that all implemented procedures are followed, according to company and customer requirements as established in specific Quality or Technical agreement.
- To manage all quality activities.
- To promote the importance of high-quality levels and the importance of a continuous improvement culture in all core company activities.
- Work with operational departments to establish procedures, standards and systems that assure and improve compliance with the cGMPs.
- Access health authorities, customer and industry requirements and ensure that these are met.
- Prepare and review quality related documentation i.e SOP Review and approval, protocols etc.
- Identify training needs and organize training sessions. Provide training.
- Prepare Product Quality Review and propose applicable action plans
- Represents client audits and health authorities' inspection.
- Prepare, conduct and document internal and external audits.
- Evaluate and approve suppliers
- Manage client complaints.
- Sc .in Chemistry, Chemical Engineering, Pharmacy or equivalent degree in a scientific area
- cGMP knowledge;
- English fluency (written and oral)
- Ability to collaborate and communicate effectively across functional groups
- Experience in Operational areas (RD or Manufacturing);Experience in Quality Assurance area is preferable.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists