Role Summary:
Accountable for investigation of quality issues related to Laboratory investigations. Responsible for deviation investigation and out-of-specification and atypical result investigation. Reviews protocols, analytical results and/ or documents associated with investigations.
Responsibilities:
- Conducting laboratory investigations (LIR/ RAAC/ Incident and QAR) through eQMS.
- Initiation of Corrective and Preventive actions related to LIR/ RAAC/ QAR.
- On time submissions of LIR/ RAAC/ Incident and QAR for closure.
- Preparing Annual Trend for Laboratory Investigations.
- Ensuring the accuracy of the Analytical data prior to closure of investigations.
- Coordinate with the CFTs for closure of investigations.
- Tracking and on time closure of action items.
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 meets the highest standards of safety and efficacy.
- Serve on cross-functional teams, conduct safety inspections, participate in investigations, recommend corrective actions, and train junior colleagues.
Here Is What You Need (Minimum Requirements)
- M.Sc in Microbiology or associate degree with minimum 8+ years of experience with relevant experience
- Strong technical skills in method validation and testing
- Experience in microbiological testings of pharmaceutical industry
- Deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
- Detail-oriented with robust knowledge of quality systems
- Familiarity with research unit clinical and analytical laboratory environments
- Effective written and verbal communication, as well as interpersonal skills
Bonus Points If You Have (Preferred Requirements)
- Relevant pharmaceutical experience.
- Method 1 investigation tools
- Strong understanding of computer system hardware, infrastructure, and networks
- Experience with Laboratory Information Management Systems (LIMS)
- Proficiency in data analysis and interpretation
- Knowledge of regulatory requirements and guidelines
- Strong problem-solving abilities
- Effective time management and organizational skills
- Ability to mentor and train junior colleagues
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Quality Assurance and Control