- Ensure that analytical equipment are maintained and calibrated accurately and timely in accordance to site procedures, CAP and regulatory requirements.
- Lead and/or participate in investigations arising from laboratory equipment/computer systems events and propose effective CAPA to minimize reoccurrence.
- Perform periodic validation review of systems /laboratory equipment in a timely manner to ensure that the validation status is maintained, and make recommendations for re-validation as required
- Lead or participate in laboratory equipment validation in accordance to site procedures and regulatory requirements, inclusive of writing, reviewing and approval of validation related documentations
- Maintain and support computer systems and laboratory equipment according to site change control and access control procedures.
- Perform accurate and thorough impact assessment on laboratory equipment, systems change control to ensure all impacted areas are adequately assessed and impacted documentation are updated in a timely manner.
- Revise, review and maintain laboratory procedures, instructions, methods to ensure compliance with regulatory, QMS, CAP and pharmacopoeia.
- Ensure a safe working environment in the laboratory and perform 6S inspection.
- Supervise, develop and motivate team members and other assigned staff to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
- Conduct effective training for laboratory staff on computer systems/equipment and relevant procedures.
- Ensure regulatory compliance, perform Level 1 audit and support L2 / L3 / L4 audits
- Ensure timeliness and accuracy of Pharmacopoeia & CAP review
Requirement:
- Min. Science degree holder with experience in the field of Chemical, Pharma or Manufacturing industry
- Good knowledge of GMP and laboratory equipment/validation
- Good knowledge of quality, laboratory techniques and laboratory compliance
- Good knowledge of regulatory expectations /CAP/ICH requirements
- Good knowledge of analytical equipment capabilities and operational needs
- Candidates with no prior experience will be considered
To apply, please visit to www.gmprecruit.com and search for Job Reference: 24919
To find out more about this opportunity, please contact Fiona Koh
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239
