Job Responsibilities:
- Report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
- Assist in generating procedures related to Manufacturing QA functions / activities
- Periodically review records to verify that quality standards for each product is met
- Prepares weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
- Responsible to maintain all testing equipment in compliance, calibration and certification.
- Promptly communicates with Operations regarding complaints, product issues/variances.
- Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
- Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles.
- Assist in the development of action plans and implementation schedules, and the verification of completed actions.
- Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
- Conduct and report the findings of internal investigations of compliance issues.
Job Requirements:
- Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
- Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.
If you are interested in the position, do kindly drop your most updated resume to [email protected]
Esther Lim Suk Hui
EA Personnel No: R18728082
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599