Purpose
The primary function is to support management of all QC laboratory systems (E.g.: Equipment, LIMS, CDS, IT related systems), participate in method technology transfer, participate in laboratory equipment technological refresh or introduction is in adherence to cGMP regulatory compliance and corporate/site procedures expectation.
Responsibilities
- Supports team task to enable adequate resources to support laboratory infrastructure (E.g.: Equipment, Method, System) needs.
- Participates in the management of laboratory equipment and IT systems in QC laboratory to ensure business continuity and system data maintenance, equipment maintenance/calibration is in a state of compliance.
- Participates in method technology transfer and laboratory equipment technological refresh/introduction activities into QC Laboratory within project timeline.
- Participates in QC laboratory long range planning to ensure laboratory infrastructure needs is secured and Data integrity plan is in place to support business and laboratory compliance.
- Author method transfer/qualification and equipment qualification documentation (E.g.: Reports, Protocol, change control, related quality documents or procedures) are in cGMP compliance to corporate/site or regulatory requirements.
- Supports and ensure timely escalation/handling of lab events or related quality actions. (E.g.: NCR, Lab Investigation, CAPA)
- Supports preparation and participate in internal/external audit, audit responses, to enable a successful audit outcome.
- Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Lead/supports CI initiatives to enable laboratory performance metrics.
- Carry out any other task as assigned by Supervisor.
Requirements
- University Degree in Science related discipline (E.g.: Chemistry, biology, pharmaceutical Sciences, or equivalent experiences).
- Minimum 1 - 3 years of pharmaceutical experience in a Quality Control Function.
Experienced in Regulatory/ Pharmaceutical requirements. - Analytical thinking with basic problem solving and writing skills.
- Motivated and independent.
- Basic GMP knowledge/Experience on QC Lab Equipment and Method transfer.
- Good communication skills and strong ability to work cross functional teams.
- Ability to work towards timeline.
