Job Description

Responsibilities:

• Supports by conducting team training to enable adequate resources to support laboratory infrastructure (E.g.: Equipment, Method, System) needs
• Lead/Supports 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
• Lead/Supports method technology transfer and laboratory equipment technological refresh/introduction activities into QC Laboratory within project timeline
• Lead/Supports 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 or Review 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)
• Acts as QC SME to support 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 and act as designee of Supervisor (as assigned)

About You:

• University Degree in Science related discipline (e.g. chemistry, biology, pharmaceutical sciences, or equivalent experiences)
• Minimum 4 - 6 years of pharmaceutical experience in a Quality Control Function
• Experienced and knowledgeable in Regulatory/ Pharmaceutical requirements
• Strong analytical thinking with good problem solving and writing skills
• Motivated and independent, a role model to the team
• Strong GMP knowledge on QC Lab Equipment and Method transfer
• Good communication skills and Strong ability to work cross functional teams
• Ability to work under pressure

Job Type: Contract
Contract length: 12 months Salary: $4,000.00 - $7,000.00 per month Experience:

• Quality Control Function: 4 years (Preferred)