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Job Description
- Ensure that a local Quality System and Standard Operating Procedures are in place for all GMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
- Report monthly Key Quality Indicators (KQis) related to GMP/GDP activities and monitor them and assure that gaps are addressed appropriately in order to mitigate risk.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
- Establish a good working relationship with the Supply Chain Management (SCM) department.
- Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations. Ensure that an effective Change Control process is in place.
- Other duties as and when assigned.
- Local GMP/GDP Quality System in place and continuously updated, as required
- GMP/GDP risks proactively identified and effectively mitigated
- The number and severity of GMP/GDP issues identified during internal and external audits
- No regulatory problem/action due to inefficient local Change Control procedure
- Training conducted according to program
Job Requirements
- Desired education:Advanced studies in pharmaceutical industry
- Fluent in English "spoken and written".
- 10 years of experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production or a directly related area.
- Knowledge and a comprehensive understanding of biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tat caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions and/or active pharmaceutical ingredient.
- Possesses knowledge and skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members, and individuals.