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Job Description
- Responsible to implement Quality Management Systems including but not limited to implementation of Deviation Management process, Customer Complaints, Change Controls, CAPAs, Risk Assessment Document Control and Vendor qualification related procedures.
- Assess and review standards, conducting gap analysis to local procedures, and support alignment activities for deployment.
- Responsible of management of all Quality Risks that might exist or might be potential risk communication and review of risks with proper escalation and approval in a timely manner for maintaining product quality.
- Supporting in Management Review Meetings.
- Support in root cause analysis for quality system trends; recommend actions to address trends.
- Assess deviations and non-conformance with regards to level of risk to product quality.
- Execute and support the audit program, including; customer audits, supplier audits, internal audits and unannounced regulatory audits.
- Issuance of Site Master File/Quality Manual.
- Responsible for providing input to APQRs as per the agreed schedule.
- Responsible for handling external audits
- Responsible to audit suppliers
Job Requirements
- Bachelor of Pharmacy or Sciences
- Good awareness and practice of Management Systems based on international guidelines and standards, e.g.;(WHO, MHRA, ISPE, PDA, PICs and FDA)
- Computer skills as general
- From 5 to 7 years of experience
