Walk-in || Senior Team Leader - Calibration
Pfizer Pharmaceutical India · Visakhapatnam · onsite · Posted 41d ago
Undisclosed10–20 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Responsible for leading calibration, qualification, maintenance, and compliance activities for engineering instruments and systems to ensure equipment reliability, regulatory compliance, operational excellence, and business continuity.
- Key Responsibilities
- Act as the Subject Matter Expert (SME) for Calibration, providing technical leadership and guidance on calibration strategies, regulatory requirements, industry best practices, instrumentation lifecycle management, investigations, deviations, and audit readiness.
- Plan, schedule, and execute calibration, qualification, and periodic requalification activities for instruments and equipment.
- Review and approve qualification documents, including URS, FAT, SAT, IQ, OQ, PQ, PRQ, and PV protocols, as well as engineering drawings and layouts.
- Maintain instrument master data and calibration records in EAMS, ensuring accuracy and data integrity.
- Ensure compliance with cGMP, GDP, 21 CFR Part 11, site procedures, and applicable regulatory requirements.
- Lead change controls, investigations, CAPA implementation, and audit observation closures.
- Support internal, customer, and regulatory audits and inspections.
- Coordinate internal and external calibration activities with vendors and cross-functional teams.
- Monitor equipment performance, calibration deviations, and breakdown trends, and implement corrective and preventive actions.
- Lead troubleshooting and reliability improvement initiatives to minimize downtime and optimize equipment performance.
- Ensure timely execution and documentation of maintenance and calibration activities.
- Identify, qualify, and manage calibration service providers.
- Support the installation, commissioning, qualification, and lifecycle management of new equipment and engineering systems.
- Drive continuous improvement initiatives focused on reliability, productivity, energy efficiency, and cost optimization.
- Coordinate engineering projects and stakeholder activities to ensure timely and successful project execution.
- Lead, coach, and develop team members through performance management, training, mentoring, and Individual Development Plans (IDPs).
- Foster a culture of GMP compliance, safety, data integrity, operational excellence, and continuous improvement.
- Provide technical support and guidance during critical maintenance, calibration, and troubleshooting activities.
- Prepare and review engineering performance reports, reliability metrics, MIS dashboards, and budget forecasts.
- Analyze equipment performance data and identify opportunities for improvement.
- Manage departmental budgets and ensure effective utilization of resources.
- Ensure compliance with Environmental, Health & Safety (EHS) requirements and company policies.
- Promote safe work practices through risk assessments, safety walkthroughs, and employee engagement.
- Maintain high standards of housekeeping, workplace safety, quality, and compliance.
- Technical Competencies
- Expertise in calibration methodologies, instrumentation, and regulatory compliance requirements.
- Hands-on experience with FAT, SAT, IQ, OQ, PQ, PRQ, and PV activities.
- Strong knowledge of cGMP, GDP, 21 CFR Part 11, cleanroom requirements, and regulatory audit expectations.
- Sound understanding of field instruments, sensors, automation systems, and calibration management software.
- Proficiency in technical documentation, root cause analysis, deviation management, and CAPA implementation.
- Leadership Competencies
- Strong problem-solving, analytical, and decision-making skills.
- Effective stakeholder management and cross-functional collaboration.
- Excellent communication, coaching, and team leadership capabilities.
- Values & Behaviors
- Demonstrate organizational values of Courage, Equity, Excellence, and Joy.
- Act as a role model for safety, quality, compliance, and data integrity.
Sourced from naukri
Skills
PRQregulatory audit expectationsInstrumentationCalibrationEquipment CalibrationPQIQSATPV21 Cfr Part 11Subject Matter ExpertiseleadershipOQFatinstrument calibrationTeam LeadGDPGMPRegulatory Compliancecleanroom requirementsSMECalibration methodologies