QC Chemist (Pharmaceutical MNC, Office Hours 5 Days)
- Perform analytical testing accurately and efficiently and in accordance to Standard Operating Procedures (SOPs).
- Sound knowledge in the compendia monograph and general chapters requirements (USP/EP/JP/IP/China and others)
- Able to assess the impact to products based on monograph changes/updates/introduction.
- Able to support regulatory submissions and queries.
- Perform equipment verification and calibration in accordance to procedures.
- Document all results in accordance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
- Ensure all quality records are attached and/or file as predetermined.
- Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
- Conduct Laboratory investigations.
- Perform maintenance and troubleshooting of laboratory equipment where required.
- Perform equipment qualification and analytical method validation where required.
- Perform laboratory equipment verification and calibration in accordance to procedures where required.
- Ensure all documentations and quality records are conducted in accordance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements and that they are filed in accordance to existing policies.
- Train fellow colleagues on written procedures and SOPs pertaining to equipment operation, analytical and microbiological test methods and general laboratory operation.
- Perform review and approval of test results in the Laboratory Information Management System (LIMS).
- Perform proactive trending of analytical results
- Analytical testing and review of test results to meet lead time in a right first time manner;
- Perform testing according to Standard Work Plan (SWP) as assigned.
- Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities.
- Monograph evaluation/assessment & assessment of compendia notices.
- Compendia monograph (pharmacopeia) tests evaluation for raw materials and finished products is a must.
- Equipment verification and calibration accordance to site or pharmacopeia standards and according to schedule;
- Ensure instrumentation is calibrated / maintained in accordance to schedule as required.
- Update relevant instrument SOPs as required to ensure it reflects current requirement and practice.
- Compliance to GMP/GLP and Quality Standards (PQS) requirements;
- Follow approved SOPs.
- Understand and comply with Data Integrity and Good Documentation Practices (GDP) requirements.
- Laboratory safety and housekeeping;
- Contribute to and participate in laboratory housekeeping and 5S program responsibilities.
- Wear Personal Protective Equipment (PPE) as required and observe safety instructions stated in Job Safety Analysis (JSAs), Standard Test Methods (STPs) and Material Application Document (MADs).
- Equipment Qualification;
- Perform IQ/OQ/PQ of new equipment with assistance from vendor.
- Conduct preventive maintenance( internal) of equipment
- Method validation;
- Perform validation of /test methods in accordance to STP and USP/JP/EP requirements
- Complete validation documents reports as required.
- Procedures Development & Review;
- Update SOPs to align with PQS and regulatory authority requirement (ICH guidelines)
- Review the SOPs periodically to ensure they are current and represent current practice and align to latest PQS.
- Update Training materials as required.
- Conduct training to new colleagues as required.
- Product Quality Review;
- Perform proactive monitoring of test result trends.
- Data trending for APRR.
- Data trending of raw materials for reduced testing opportunities.
- Laboratory investigation;
- Conduct and document laboratory investigations in a timely manner according to SOPs.
- Change Control Implementation;
- Raise and complete change controls for changes with GMP impact.
- Coordinate change controls to completion in a timely manner.
- Min Degree in Chemistry or equivalent with at least 2-4 years of relevant experience in the pharmaceutical / chemical industry.
- Experience in operating laboratory equipment such as HPLC, GC , KF Titrators.
- Working knowledge of cGMP and regulatory requirements related to Quality is an advantage
- 5 days office hours
If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: QC Chemist - Leon)
Leon Leong De Cong
Recruit Express (Healthcare & Lifesciences Division)
EA License: 99C4599
Recruit Express Pte Ltd