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Senior Laboratory Quality Control Specialist
3 weeks ago
Our organization seeks a highly skilled Quality Control Specialist to join our team in the laboratory. This role involves conducting quality control analyses in compliance with laboratory and analytical methods, ensuring that quality, cGMP, health, safety, and environmental standards are met.
Job Purpose
The incumbent will report to the QC Chemist and be responsible for performing and carrying out analytical testing in compliance with specifications, analytical methods, laboratory methods, and pharmacopoeia requirements. The specialist will also assist in other functions such as documentation and preparation of standard operating procedures.
Responsibilities
- Assist in conducting on-the-job training of other quality control specialists, incorporating cGMP and safety procedures.
- Perform and carry out analytical testing in compliance with specifications, analytical methods, laboratory methods, and pharmacopoeia requirements.
- Assist in monitoring the calibration and maintenance program for laboratory instruments/equipment and ensure compliance with established schedules.
- Assist in qualifying laboratory equipment and validating analytical methods.
- Ensure that analyses are carried out and reported in accordance with GLP (Good Laboratory Practices). Ensure that analyses are completed on time and are consistent with business requirements.
- Assist in conducting OOS and atypical results investigation.
- To ensure that qualification, preventive maintenance, and calibration of laboratory equipment are carried out.
- Report and trend test results.
- Plan and assure cGMP-compliant quality testing and documentation according to schedule.
- Prepare laboratory reagents in compliance with GLP and laboratory SOP requirements. Source reagents/laboratory consumables keeping in view departmental targets.
- Assist in other functions such as preparation of standard operating procedures and documentation, etc. Participate in departmental activities as and when required. Maintenance and development of all required laboratory documents (i.e., raw data sheets, log books).
- Responsible for electronic raw data handling in compliance with regulations and guidelines.
- Responsible for inspection and audit preparedness with respect to cGMP and EHS issues.
- Ensure safe working in the laboratory by practicing and communicating safety.
- Other responsibilities that are not included in the above but are related to quality control and in accordance to internal guidelines and SOP.
Requirements
- Possess a year's hands-on analytical testing experience in a lab environment, preferably from the pharmaceutical industry.
- Familiar with analytical equipment (e.g., HPLC, GC, etc.).
- Will to work shifts on a rotational basis.
- Analytical, methodical, and quality-conscious.
- Good knowledge of FDA regulations and cGMP.
- Possess a Diploma in chemistry/chemical process technology/bio-process technology; or an ITE graduate.
