Quality Control Supervisor

2 weeks ago

Thành phố Hồ Chí Minh, Vietnam GSK Full time

**Site Name**: Vietnam - Ho Chi Minh City
**Posted Date**: Nov 28 2024
**Job Purpose**:

- The position will ensure quality operations and systems in the GSP warehouse are in compliance with the rules and regulations of the regulatory agencies (WHO GSP, GDP and part of GMP) and that the GSK policies and procedures are being followed.
- The position will provide support to the QA Manager to ensure product quality compliance through E2E product flow.
- Generates and secure records to comply with regulatory requirements, (GSP, GDP and part of GMP and Internal Quality Standard Operating Procedures) within the organization.
- Perform the management of monitoring program to assure activities of all sections are in compliance with applicable GSP, GDP, part of GMP and GSK policies and LSOPs.
- Achieve and sustain the state of compliance to ensure deliverance of quality products to the customer.
- Generates and secure records to comply with regulatory requirements, (GSP, GDP) and part of GMP and GSK QMS.
- Ensure completion of validation, re-qualification and periodic validation review for GSP warehouses and computer systems.

**Key Responsibilities**:

- Regulation compliance check of incoming goods and make sure right status of received products.
- Decision making to release for sale/quarantine/reject products and repacking materials.
- Verification of irregular goods, quarantined/suspended stock, recalled products.
- Supervise all transaction on quarantined/ rejected stock.
- Verification of returned goods to make sure product quality as requirement of processes. Authorising the return to saleable stock of any returned medicines.
- Coordinate with warehouse for repacking plan. Ensure repacking activities are carried out in line with processes, manufacturer’s instruction and regulation/standard compliance.
- Supervise and implement repacking of products. Ensure that the repacking process is carried out in accordance with the prescribed requirements. Products to the market must have information in accordance with the requirements of the law.
- Verify, approve for results from operation activities (i.e. storage condition monitoring, pest control, device calibration)
- Perform the validation and requalification per GSK requirement regularly in regard to facilities, utilities, equipment, cleaning, transport processes.
- Perform validation activities (i.e. Temp. mapping for storage areas, cold box)
- Provides support for the implementation and/or maintenance of a documentation structure, SOP training and related local processes, enabling common Quality Systems and documents to be used within affiliate, including maintenance of accuracy of quality records, version updates and effectivity, periodic record review, obsoleting and archiving.
- Ensure documentation control (i.e. SOP distribution, training records, batch records) is properly managed with assigned scopes.
- Generate and update controlled documents (e.g., procedures, forms, reports) as needed, to ensure compliance with applicable quality objectives and regulatory requirements.
- Ensure change control/deviation documents related to site activities are verified and well documented.
- Deviation and failure investigation.
- Tracks the shipping complaints associated with the distribution to ensure they are appropriately reported, recorded and resolved on a timely basis.
- Participate in quality incident investigation and Lead or co-ordinate investigations and corrective and preventative action recommendations related to product supply chain.
- Coordinating and performing promptly any recall operations of medicinal products.
- Participate and support audits, follow up post-audit if requested.
- Quality inspection (management of monitoring).
- Internal audit (Independent business monitoring)
- Participate in external compliance audits, regulatory inspections as required.
- Monitor third-party CAPAs.
- Support to achieving GSP, GDP and part of GMP certification, to ensure a compliant GSK Quality Management Systems.
- Perform & support gap analysis and risk assessments on processes and evaluate compliance to relevant GSP, GDP and part of GMP regulations/guidelines & implement/support the implementation of corrective actions, prevent action.
- Perform LSOPs quality training and personnel qualification programs (day to day, routine operational basis)
- Ensures all personnel are trained in GSP, GDP for their own duties, including product identification, the risks of falsified medicines and specific training for products requiring more stringent handling.
- Perform other quality reports when requested.
- Internal/External Customer & Partners Satisfaction
- Build network with cross functions in order to build a transparent and consistent working environment within the company.
- Assist GSK Vietnam build quality culture and quality event
- Training/ skill enhancing
- Participate in training course in My-learning/conducted by local Quality team/Region Quality team/CERPs/SAP/

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