Assistant Manager Operational Quality
Job Purpose :
To ensure that products released for sale have been manufactured and packed in accordance with the licensing requirements, Quality Management System, Good Pharmaceutical Manufacturing Practice and business requirements, and to promote quality / compliance within their area of operations.
To ensure cGMP practices and quality standards on processes, products personnel and systems ensuring compliance to control procedures and regulations
Educational Requirements & Experience Requirements :
Required Experience : 4 - 6 years; Sterile experience is preferred
Key Responsibilities : In-Process Control :
In-Process Control :
Ensure In-Process checking, Line clearance during operations (oversight) are according to SOPs, understanding of core Operational Quality processes and taking action to mitigate risk.
Ensure that manufacturing, filling and packing activities are performed according to BMR, BPR and relevant SOPs.
Product Release :
Compile and review batch documents and release products, ensure that manufacturing, filling and packaging activities are performed according to BMRs, BPRs and relevant SOPs.
Ensure that batch dossiers are retained as per local regulatory and GSK record retention policy.
Deviation Handling :
Rectifying or reporting any deviations from cGMP or the Quality Management System.
Providing advice to line management to ensure that cGMP compliance requirements are built into the site's core practices.
Ensure that product quality issues are correctly investigated and that appropriate corrective and preventive actions are implemented.
Support in investigations of products failing to meet standards, support and coordinate with stake holders for the CAPA preparation.
CAPA Plan Handling
Ensure all QMS requirements for Operational Quality including Self-inspections, SOP status, Trainings, CAPA closure, Gap analysis actions and others are timely completed and communicated to relevant stake holders.
Customer Complaints :
Ensure market complaints are handled effectively and timely as per standard procedures.
Ensure complaints are timely logged, investigated, and responded to stakeholders
Environment, Health & Safety
To ensure that EHS practices are being maintained.
Implement and follow EHS standards and guidelines in Operational Quality.
Reporting EHS adverse events.
Periodic Product Reviews
Collect and compile data for Periodic Product Review.
Ensure that Periodic Product Reviews are carried out as per approved procedure.
Review Validation Protocols and Reports, BMRs, BPRs, Product transfer documents, SOPs and any other documents having impact on product quality for Quality Compliance.
Support in site validation activities by providing OQ input.
Ensure Validation batches are released as per specified requirements.
Site Archive Room, Batch document room & Retained Sample Room
Ensure that compliance related documents are retained as per GSK record retention policy.
Ensure that batch record rooms, storage, archiving and traceability of the documents are managed.
Ensure that retained samples room, storage, archiving and traceability of the samples are managed.
Other Skills :
1) Computer literacy, minimum to access and utilize emails for official correspondence
2) Use of MS-Office (Word, Excel, PowerPoint) at least to a moderate level
3) Good communication and presentation skills
Contact information :
You may apply for this position online by selecting the Apply now button.
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