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:
Responsible for supporting QC laboratory infrastructure/system needs (e.g. Equipment, Method, QC Systems) for routine usage.
Develops technical competency and jointly creates a great place to work in.
Supports financial spending are within the latest best estimates.
Supports QC infrastructure/technological needs through long range plan execution.
Build aspiration to be SME for QC Operational readiness (E.g.: QC system or method transfer), infrastructure/instrumentation (E.g.: Advance technology) and compliance readiness (Eg: QC System, Lab compliance, Data integrity) per cGMP/EHS/Regulatory compliance global or site procedures expectations.
Authors lab documentation, method transfer/qualification and equipment qualification (E.g.: Reports,
Protocol, change control, related quality documents or procedures) are in cGMP compliance to corporate/site or regulatory requirements.
Participates in resolution of laboratory investigation/exception or actions for closure.
Participates in internal/external audits and enables audit response for a successful outcome in sustaining licenses to operate.
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 QC laboratory long range plan to ensure laboratory infrastructure needs is secured and Data integrity plan is in place to support business and laboratory compliance.
Participates in method technology transfer and infrastructure/laboratory equipment technological introduction activities into QC Laboratory within project timeline. (As required)
Supports CI initiatives to enable laboratory performance metric.
Any other task/projects assigned by line manager.
Requirements:
Diploma in Sciences (i.e. Applied Chemistry, Biomedical, Biotechnology, Pharmaceutical), Pharmacy, or equivalent.
Bachelors in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent.
