- 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
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
------------------------------------------------------------------------------------------------------------------------------------------------------------
This is in partnership with the Employment and Employability Institute Pte Ltd (e2i).
e2i is the empowering network for workers and employers seeking employment and employability solutions. e2i serves as a bridge between workers and employers, connecting with workers to offer job security through job-matching, career guidance and skills upgrading services, and partnering employers to address their manpower needs through recruitment, training, and job redesign solutions. e2i is a tripartite initiative of the National Trades Union Congress set up to support nation-wide manpower and skills upgrading initiatives.
By applying for this role, you consent to GMP Recruitment Services (S) Pte Ltds PDPA and e2is PDPA.
Demo
Islandwide,
Full Time