Associate Quality Control (Pfizer)

Roles and Responsibilities

What You Will Achieve

In this role, you will:

• Perform method transfers/ validations / method verifications to the complex analytical techniques

• Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.

• Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.

• Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.

• Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.

• Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.

Here Is What You Need (Minimum Requirements)

• Master’s degree in chemistry/ pharmacy with 2 - 5 years of experience in Analytical Method Transfer / Validation)

• Qualified in multiple analytical techniques (HPLC, GC, UV‑Vis, FTIR, Karl Fischer, and pH meters)

• Demonstrated technical skills in method validation and testing

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

• Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards, encompassing protocol preparation, execution, approval of validation summaries, and coordination with cross‑functional teams.

• Conduct test method GAP assessments against USP, EP, BP, and JP requirements for New Product Introduction (NPI).

• Execute and document analytical method verification and method transfer activities.

• 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

• Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation

Bonus Points If You Have (Preferred Requirements)

• Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography),GC techniques

• Proven track record in leading continuous improvement projects

• Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis

• Strong problem-solving skills and attention to detail

• Ability to manage multiple priorities and meet deadlines.

• Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels

• Adaptability and willingness to learn new techniques and procedures