• Perform analytical testing accurately and efficiently in accordance to Standard Operating Procedures
• Perform equipment verification / calibration / maintenance in accordance to procedures
• 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
• 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
• Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory
• 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 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 company Quality Standards (PQS) requirements;

- Follow approved SOPs

- Understand and comply with Data Integrity and Good Documentation Practices (GDP) requirements

• Equipment Qualification;

- Perform IQ/OQ/PQ of new equipment with assistance from vendor

- Conduct preventive internal maintenance of equipment

• Method validation;

- Perform validation of /test methods in accordance to STP and USP/JP/EP requirements

- Complete validation document 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

• Product Quality Review;

- Perform proactive monitoring of test result trends

- Data trending for APRR

- Data trending of raw materials for reduced testing opportunities

• Change Control Implementation;

- Raise and complete change controls for changes with GMP impact

- Coordinate change controls to completion in a timely manner

Requirements:

• Diploma / Degree in Chemical Process Technology or related
• A minimum of 5 years QC experience in pharmaceutical or related industry
• Good Manufacturing Practices (GMP) & Good Laboratory Practices (GLP)
• Good experience on HPLC & GC testing and Empower software

Interested Applicants

Kindly forward your detailed resume in MS Word format

(Indicating Reason of Leaving, Availability Period, Last Drawn & Expected Salary) to

selina.lim@experis.com.sg

Personnel Reg No: R1333126

EA Licence No: 02C3423

We regret that only shortlisted candidates will be notified

Selina Lim Siew Yen EA License No.: 02C3423 Personnel Registration No.: R1333126