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Associate Manager – BQ QMS & Compliance
PfizerAssociate Manager overseeing laboratory quality investigations at Pfizer in India. Ensuring compliance with quality standards and conducting thorough investigations in a global pharmaceutical environment.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in laboratory investigations, including deviation and out-of-specification investigations, while ensuring compliance with quality systems and effective communication with cross-functional teams. Proficient in method validation and microbiological testing within the pharmaceutical industry.
Highest-signal resume keywords
M.Sc In Microbiology8+ Years Experience In Pharmaceutical IndustryMethod Validation And TestingMicrobiological TestingQuality Systems Knowledge
ATS Keywords
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Hard Skills
Laboratory InvestigationsDeviation InvestigationOut-Of-Specification InvestigationAnalytical Data AccuracyCorrective And Preventive ActionsAnnual Trend PreparationEQMSLIR/ RAAC/ QAR ManagementAnalytical Results ReviewAction Item Tracking
Soft Skills
Detail-OrientedEffective CommunicationInterpersonal Skills
Industry Keywords
Pharmaceutical ManufacturingQuality Assurance OperationsClinical Laboratory EnvironmentsResearch Unit
About the role
Key responsibilities & impact- 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
- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- Quality assurance and compliance culture
- Opportunity to impact patient care
- Professional development opportunities