Pfizer, a globally renowned leader in the pharmaceutical industry, is committed to improving health and well-being worldwide. Through a steadfast dedication to research, innovation, and development, Pfizer has consistently delivered safe and effective medications. With a strong emphasis on a science-based, risk-compliant quality culture, Pfizer supports patient needs through flexible and customer-focused solutions. The company operates with the mission of ensuring the highest standards in product quality and safety.
Responsibilities in the Job
As an Executive in Quality Control at Pfizer’s Goa location, you will play a pivotal role in maintaining and enhancing the quality assurance standards that the company is known for. Your duties will include:
- Media Preparation: Assist in the preparation and sterilization of media and manage stocks.
- Culture Maintenance: Oversee the maintenance of master cultures and prepare Cryo vials.
- Handling Bio Cultures: Manage the receipt, storage, and handling of Bio ball cultures.
- Analysis and Testing: Conduct water analysis, microbial limit tests, sterility testing, bacterial endotoxin tests, container closure integrity tests (CCIT), and micro challenge studies.
- Documentation and Records: Update and file training records to ensure compliance with current testing protocols.
- Sample Management: Perform the sampling and labeling of materials following defined procedures and verify the accuracy of equipment.
- Data Interpretation: Analyze data for accuracy and precision, assess potential impacts on Good Manufacturing Practices (cGMP), and recommend corrective actions.
- Compliance with GMP/GLP: Ensure all documentation aligns with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
- Standard Operating Procedures (SOPs): Review and revise SOPs, analytical methods, and other relevant documentation.
- Product and Material Analysis: Perform analysis on finished products, raw materials, and components, and maintain computerized database records.
- Microbiological Protocols: Conduct microbiological protocols as needed.
Qualifications
To be eligible for this role, candidates must meet the following qualifications:
- Educational Background: Bachelor’s degree is a must.
- Technical Expertise: Demonstrated technical skills in method validation and testing.
- Regulatory Knowledge: Ability to comprehend compendial methods, SOPs, technical procedures, and government regulations.
- GMP Understanding: Sound knowledge of Good Manufacturing Practices and their application.
- Organizational Skills: Exceptional ability to multitask and manage time effectively.
- Communication Skills: Strong written and verbal communication skills.
Skills
Candidates with the following skills will stand out:
- Analytical Techniques: Hands-on experience with HPLC (High Pressure Liquid Chromatography) is advantageous.
- Continuous Improvement: Experience leading continuous improvement projects.
- Methodologies: Familiarity with lean manufacturing, Six Sigma methodologies, and statistical analysis is a plus.
