20 days old

QC Chemist

Tunas, MO 65764
+ Responsibility:

+ Perform analytical method transfer in accordance to Standard Operating Procedures (SOPs)

+ Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.

+ Perform cleaning method development and validation

+ Able to assess the impact to products based on compendial monograph changes/updates/introduction.

+ Able to support regulatory submissions and queries.

+ Perform method validation and verification as per SOP.

+ Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.

+ Conduct Laboratory investigations.

+ Train colleagues in hands on training of instruments and methods written

+ Perform review and approval of test results.

+ Able to write postion paper, protocols, reports and test procedures.

+ Ability to handle QTS actions and investigations. Accountability:

+ Analytical testing, method transfers 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.

+ Compendia monograph (pharmacopeia) tests evaluation for raw materials and finished products.

+ Method verification in accordance to site or pharmacopeia standards and according to schedule;

+ Ensure instrumentation is calibrated / maintained in accordance to schedule as required.

+ Support to QC for method trouble shooting

+ Support Post transfer method support

+ Execute method equivalency study

+ Evaluate method robustness challenges and modify the method to improve method robustness if required.

+ Involve in regular meeting with donating site and facilitate the smooth transfer of the methods.

+ Update relevant instrument SOPs as required to ensure it reflects current requirement and practice.

+ Compliance to GMP/GLP and Pfizer Quality Standards (PQS) requirements;

+ 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).

+ Perform test method validation & cleaning method validation of test methods in accordance to STP and USP/JP/EP requirements

+ Complete validation documents reports as required.

+ Update SOPs to align with PQS and regulatory requirement (USP, ICH guidelines etc)

+ Conduct and document laboratory investigations according to SOPs.

+ Raise and complete change controls for changes with GMP impact.


+ Degree or Diploma in Science (preferably Chemistry) or Chemical Process Technology.

+ For Diploma holder, a minimum of 5 years QC experience in the pharmaceutical or related industry.

+ For Degree holder, a minimum of 2 years QC experience in the pharmaceutical or related industry.


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control
Posted: 2020-10-05 Expires: 2020-11-04

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QC Chemist

Tunas, MO 65764

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