QC Associate - System Support (Equipment Qualification/ Validation/Pharma)
Location : Gul Circle
Salary Up to $4,500 depending on experience
Completion Bonus 1 Month
Our client delivers vital healthcare solutions worldwide, powered by the precision and dedication of its Manufacturing & Supply teams. With your talent, they can expand their impact-protecting more people and offering hope to patients and their families.
Responsibilities:
- Updating the site validation master plan and procedures related to ALCM and CPV of GXP lab equipment.
- Support periodic analytical method control trend review/ investigation and data evaluation on method performance, recommend method improvements where appropriate.
- Support the life cycle management of the QC lab equipment i.e qualification of QC equipment and periodic review are maintained for their intended use.
- Decommissioning of QC equipment and maintaining up to date the lab equipment inventory.
- Participate in proper documentation issuance and review of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports.
- Support laboratory qualification Investigation and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.
- Providing support during regulatory inspections and audits.
- Prepare metrics and monitoring data for the qualification and validation activities, to identify trends and issues, during life cycle management of QC laboratory equipment.
- Support initiatives for continuous improvement in QC support processes related to lab equipment management in coordination with QC excellence team.
- Support invalid assay trending program in the QC laboratory.
- Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements.
- Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records related to these tasks.
Requirements
- Minimum of two (2) years of experience in quality control within the pharmaceutical industry, including good knowledge of Good Manufacturing Practices (GMP) and regulatory requirements, with hands-on exposure and theoretical requirement of QC laboratory instruments and ALCM management.
- Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology
- Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.
- Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.
- Good understanding of good laboratory practices, good documentation practice and data integrity requirements.
- Experienced in analytical method continuous monitoring requirements.
- Strong interpersonal relationships to establish the partnerships necessary for the development of the Quality culture.
Lim Pey Chyi - [Confidential Information]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
