Quality Control Analytical (Associate Manager /Manager

Job Responsibilities

Ensure adherence to cGMP requirements.

Ensure adherence to EHS compliance at QC Analytical Laboratory.

Ensure Good Documentation Practice (GDP) is in place and applied in recording of QC daily activities for easy traceability and facilitate audit requirement.

Ensure the proper housekeeping and cleanliness is maintained in QC Analytical department

Preparation and continuous improvement of all relevant SOPs, EOPs, Specifications and ensure those procedures are revised and updated in accordance to stipulated interval and as per cGMP requirement / latest pharmacopoeia.

Ensure proper safe and regular disposal of laboratory waste such as solvent, reagents and etc. following EHS Department and local regulation.

Daily monitoring of Drug Product and Drug Substance incoming and retest raw materials, Packing Materials and Consumables in SAP system.

Coordinate and assign activities to team members for routine test analysis and ensure task segregation is well organized to meet timelines.

Shall co-ordination with other departments to resolve day to day activities with respect to Raw Material, Packing Materials and Water testing as per the specified standards.

Review of Analytical reports related to Raw materials, packing Materials and Water, Finished product and stability samples.

Approval/Rejection of Raw Materials, Packing Materials and Water

To update Raw Materials and Packaging Material of Drug Product on monthly basis to Global QC.

Involve in Quality Management System activity of setting and monitoring metrics of performance and KPI’s of the QMS team in QCA.

Handling of all QMS elements (Deviation, OOS, OOT, CAPA, CC) by ensuring the raising, handling, investigations, submissions and closures and perform accordingly for QCA department.

Perform and review investigations of Deviations, OOS & OOT raised by QCA personnel and coordinate with QA for the closure.

Liaise and coordinate with other department e.g. Production, QA, Regulatory Sciences, etc. for issue regards to Raw Materials and Packaging Materials.

Handling of Lab Incident investigation and ensuring proper closure of the lab incident.

Facilitate an internal / external audit in Quality Control Analytical.

Responsible for preparation for any revision and new of relevant document and issuance of change control form and deviation.

Preparation and review of Study protocols

SAP and LIMS activities as per designated roles.

Requirements

Bachelor’s Degree and Master's Degree in Biotechnology, Biochemistry and Microbial Biotechnology or equivalent field.

15 - 20+ years of hands-on experience in QC Analytical department

Experience in pharmaceutical/medical device in QCA