Associate Manager - BQ QMS & Compliance
About the role
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
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
Questions about this role
Want AI Applyd to auto-apply to roles like this?
We tailor your resume per posting, fill the forms, and track replies for you.