20 days old

QC Chemist

Pfizer
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.



Requirement:



+ 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.



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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

Pfizer
Tunas, MO 65764

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