Associate - Quality Control

Pfizer Pfizer · Pharma · Vizag, India

This role is responsible for performing method transfers, validations, and verifications of complex analytical techniques within a quality control setting at Pfizer. The Associate will interpret and evaluate data for accuracy, ensure compliance with cGMP and GLP, review and revise SOPs, and conduct analyses on finished products, raw materials, and components. The role requires a Bachelor's or Master's degree in Chemistry or Microbiology with relevant experience in analytical testing and a strong understanding of various analytical techniques and regulatory standards.

What you'd actually do

  1. Perform method transfers/ validations / method verifications to the complex analytical techniques
  2. Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.
  3. Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.
  4. Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.
  5. Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.

Skills

Required

  • Bachelor's Degree in Chemistry/ Microbiology with Minimum 4-5 years in Analytical testing / Master's Degree in Chemistry/ Microbiology with Minimum 2-3 years in Analytical testing
  • 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

Nice to have

  • 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

What the JD emphasized

  • cGMP
  • Good Manufacturing Practices
  • Good Laboratory Practices
  • ICH Q2 (R1/R2)
  • USP
  • EP
  • BP
  • JP