Job Description

Locations

• India - Vizag

Skills Required

• strong background in Quality Controlintermediate
• Quality Controlintermediate
• cGMP compliance for Quality Control laboratoriesintermediate
• wide range of analytical techniquesintermediate
• environmental testingintermediate
• QC instrumentationintermediate
• common AI toolsintermediate

Required Qualifications

• Ensure equipment qualification and lifecycle compliance for QC laboratory instruments, including IQ/OQ/PQ activities. (experience)
• Oversee calibration, preventive maintenance, and requalification of QC equipment in accordance with approved schedules and regulatory requirements. (experience)
• Ensure Equipment Qualification protocols, reports, deviations, and change controls are reviewed and approved. (experience)
• Collaborate with Engineering, Validation, and QA to support: (experience)
• New equipment introduction (experience)
• Decommissioning and replacement activities (experience)
• Ensure data integrity, ALCOA+ principles, and computerized system compliance for analytical instrumentation. (experience)
• Education: B. Pharm / M. Pharm / M.Sc. (experience)
• Experience: Minimum 10+ years of pharmaceutical industry experience with a strong background in Quality Control. (experience, 10 years)
• Extensive knowledge of cGMP compliance for Quality Control laboratories, including, testing, stability management, lab investigations, equipment qualification, and data integrity. (experience)
• Demonstrated experience in:Analytical testing, stability management, and retention samplesEquipment qualification, calibration, and maintenance oversightAudit handling and regulatory inspectionsIncident, CAPA, Change Control managementPeople leadership and performance management (experience)
• Proficiency in a wide range of analytical techniques and QC instrumentation. (experience)
• Education: B. Pharm / M. Pharm / M.Sc. (experience)
• Experience: Minimum 10+ years of pharmaceutical industry experience with a strong background in Quality Control. (experience, 10 years)
• Extensive knowledge of cGMP compliance for Quality Control laboratories, including, testing, stability management, lab investigations, equipment qualification, and data integrity. (experience)
• Demonstrated experience in: (experience)
• Analytical testing, stability management, and retention samples (experience)
• Equipment qualification, calibration, and maintenance oversight (experience)
• Audit handling and regulatory inspections (experience)
• Incident, CAPA, Change Control management (experience)
• People leadership and performance management (experience)
• Proficiency in a wide range of analytical techniques and QC instrumentation. (experience)

Preferred Qualifications

• Master's degree (degree)
• Knowledge in the application of statistical tools, root cause analysis, and/or six sigma methodologies (experience)
• Experience with environmental testing, utility monitoring, analytical testing, microbial identification, and sterility testing (experience)
• Expertise in QC instrumentation, qualification, and troubleshooting (experience)
• Experience in setting requirements for the transfer of methodology from Research and Development (R&D) (experience)
• Ability to manage projects and ongoing work activities of moderate complexity (experience)
• Excellent verbal and written communication skills (experience)
• Ability to foster teamwork and colleague development (experience)
• 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 (experience)
• Knowledge in the application of statistical tools, root cause analysis, and/or six sigma methodologies (experience)
• Experience with environmental testing, utility monitoring, analytical testing, microbial identification, and sterility testing (experience)
• Expertise in QC instrumentation, qualification, and troubleshooting (experience)
• Experience in setting requirements for the transfer of methodology from Research and Development (R&D) (experience)
• Ability to manage projects and ongoing work activities of moderate complexity (experience)
• Excellent verbal and written communication skills (experience)
• Ability to foster teamwork and colleague development (experience)
• 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 (experience)
• 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. (experience)

Responsibilities

• Leadership & People ManagementLead, coach, and manage Quality Control teams through goal setting, performance reviews, feedback, development planning, and succession readiness.Identify development needs, foster teamwork, inclusion, and a culture of accountability and continuous improvement.Manage workforce planning, leave management, and performance appraisal cycles.Actively share knowledge, encourage innovation, and support risk‑based decision making.
• Quality Control & Laboratory OperationsPlan, manage, and oversee analytical activities related to:In‑process, finished product, stability, process validation, exhibit batch, market complaint, and retention sample testingStability sample pulling, testing, protocol approval, compilation reports, and annual stability report submissionsVisual inspection of retention samples per approved schedulesEnsure timely review, approval, and completion of all QC activities in alignment with site KPIs.Review and approve, Laboratory investigations, QC documentation including raw data, protocols, reports, and SOPs in compliance with cGMP.
• Equipment Qualification, Calibration & Lifecycle ManagementEnsure equipment qualification and lifecycle compliance for QC laboratory instruments, including IQ/OQ/PQ activities.Oversee calibration, preventive maintenance, and requalification of QC equipment in accordance with approved schedules and regulatory requirements.Ensure Equipment Qualification protocols, reports, deviations, and change controls are reviewed and approved.Collaborate with Engineering, Validation, and QA to support:New equipment introductionDecommissioning and replacement activitiesQualification impact assessments for changesEnsure data integrity, ALCOA+ principles, and computerized system compliance for analytical instrumentation.
• Stability ManagementApprove and manage stability and retention sample requests, protocols, reports, and annual submissions.Ensure sponsor‑site stability samples, review of shipment temperature excursions, and execution of stability studies at site.Ensure PRQ and qualification of stability chambers as per approved schedules.
• Compliance, Audits & Quality SystemsEnsure alignment with cGMP, regulatory requirements, and Pfizer Quality Standards across all QC activities.Represent CQ during internal, external, customer, and regulatory audits and inspections.Support timely investigation and closure of Incidents, Deviations, CAPAs, and Change Controls, including cross‑functional impact assessments.Ensure personnel safety, safe material handling, and adherence to EHS requirements within QC laboratories.
• Continuous Improvement & Technical ExcellenceGuide analysts in the application of continuous improvement tools such as standard work, visual management, LEAN, and Six Sigma methodologies.Drive simplification, digitization, and efficiency improvement initiatives across CQ processes.Provide technical expertise in troubleshooting analytical methods, instruments, and laboratory issues.Support method transfers from R&D to QC and ensure readiness for routine testing.
• Collaboration & Business PartnershipPartner with Manufacturing, QA, Engineering, R&D, Supply Chain, and external customers to support site objectives and timelines.Establish and monitor departmental performance metrics to drive operational effectiveness.Communicate complex technical concepts clearly, solicit feedback, and influence stakeholders using sound scientific and business rationale.

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