QC Chemist

zer provide safe drugs to its patients.

Your qualifications of unique Quality Control instruments will help us meet accuracy specifications for sample management, retains managements, interpretation and evaluation. You will also be relied on for establishing requirements for the transfer of methodology from R&D.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Perform analytical and basic microbiological testing accurately and efficiently and in accordance to Standard Operating Procedures (SOPs).

• 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.

• Performs quality review of completed test records , approval of QC samples/lot disposition in the Laboratory Information Management System (LIMS) and release of immediates, raw materials, solvents and packaging materials.

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

• 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.

• Perform basic microbiological testing such as endotoxin level in water and products.

• 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.

• Participate actively and contribute to site project teams.

• 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 and microbiological test results.

• Prepare analytical and microbiological for Annual Product Review Reports (APRR).

• Advise on the significance of test results and follow up with appropriate course of actions.

• Actively participate in Safety initiatives, typically a role model for other analyst. Ability to perform investigation related to EHS.

• Participate in 5S team initiatives and practice good housekeeping.

• Lead and conduct laboratory investigations/incidents such as out of specification investigation and equipment troubleshooting investigations, identify root causes and implement appropriate corrective action and preventive measures.

• Participate in Analytical Method Transfer Exercise and independently resolve issues associated with test methods

• Develop and validate test methods as required.

• Lead and manage laboratory equipment validation project independently.

• Review test reports and ensure that all laboratory documents are in a constant state of regulatory compliance and inspection readiness.

• Develop test methods or instrument Standard Operating Procedures (SOPs), write and update Quality Procedures.

• Plan and deliver technical training to colleagues. Developed and review training materials as required e.g. Basic lab techniques.

• Close coordination with cross function colleagues / Vendors to achieve desire outcome ( e.g. Lab equipment installation/ Validation/ Service contract / External contract lab testing fulfillment).

• Commitment to work and positive influencer/role model/motivate others for overall operational excellence.
  Job Related Requirements:

• Demonstrated leadership and customer service skills.

• Effective problem solving skills.

• Strong verbal, written communication and presentation skills.

• Demonstrated ability to perform in a team.

• Comprehensive knowledge of cGMPs and appropriate regulations.

• Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment.

• Experience in Empower software/ SAP will be an added advantage.
  Accountability:

• Analytical testing

• Laboratory Non-conformance and Investigation management.

• Laboratory safety and housekeeping

• Procedures Development & Review

• Training

• Change Control Implementation

Qualifications

Must-Have

• Bachelor's Degree

• Demonstrated technical skills in method validation and testing

• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations

• Knowledge of Good Manufacturing Practices and its application standards, processes and policies

• Excellent organizational skills and strong ability to multi-task

• Strong written and verbal communication skills

Nice-to-Have

• Laboratory work experience with analytical HPLC (High Pressure Liquid Chromatography) technique

• Experience leading continuous improvement projects

• Knowledge of lean manufacturing, six sigma methodologies, and statistics

Work Location Assignment: On Premise

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

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