Associate - Quality Control
- Pfizer
- 2 - 5 years
- Visakhapatnam
- 3 days ago
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Job Description
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.
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)
- 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, UVVis, 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 crossfunctional 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
Work Location Assignment: On Premise
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Visakhapatnam
Keyskills: sterile injectables Analytical Method Validation JP requirements Analytical Method Transfer CGMP governmental regulations Karl Fischer NPI USP Quality Inspection PH METER FTIR GC Standard Operating Procedures HPLC Quality Control
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