- Responsible for Analyst Qualification, Calibration, Qualification of Instrument/ Equipments, SOP, Column Management, Procurement and Capex, Preventive Maintenance, Computer system Validation, Audit compliance and Working standard activity.
- Ensure planning and execution of all activity in GLP section.
- Responsible for review of SOPs, GTPs, specification, Protocol for stability, Protocol of Analytical Method Validation/ Transferred/ verification and other non-routine activity.
- Responsible for Approval of Calibration of Instrument/Equipments.
- Responsible for Usage Decision for Calibration of Instrument/ Equipments through SAP and review of preventive Maintenance through SAP.
- Responsible for Investigation of non-conformities like deviations, out of specifications, out of trend, failures, Market complains etc. and derive appropriate Corrective and preventive actions.
- Responsible for execution and review of software validation documents.
- Issuance of calibration data sheet and test data sheet for RM, PM, FP, INT and stability.
- Responsible for Preventive Maintenance and AMC of Equipment and instrument.
- Review of Temperature and Humidity record, Daily Monitoring Record, External Calibration Record, IQ, OQ, PQ record of instrument/Equipment.
- Responsible for review of change control, deviation, CAPA, incident, Reprocess in QAMS.
- Responsible for review of Effective Monitoring of CAPA.
- Coordinate with RA for filling the requirements of various regulatory submissions.
- Responsible for preparation of AMC/CMC PO.
- Responsible for initiation of capex items.
- Laboratory maintenance as per GLP compliance.
Required Candidate profile
- Relevant Exposure in API/Bulk Drug /Pharma/ Industry with Process Safety implementation, Excellent Communication & Interpersonal Skills.
- Scored 60% marks / 1st Class in their highest qualification, if having less than 05 years of post qualification experience.
- Behavioral Attributes: Customer Focus, Effective communication skills, Execution Excellence, Building Positive Working relationship, Decision Making through strategic thinking, Achievement orientation, Developing others.
- Physical Capabilities : Normal skin and appendages, no chest diseases no physical deformity/ disability/ disorder/ vision bilateral corrected, no color blindness, normal blood pressure, no communicable/ infectious/ occupational diseases.
Perks and BenefitsSalary no bar for deserving candidates
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Production, Manufacturing, Maintenance
Role:Quality Assurance/Quality Control Manager
Desired Candidate Profile
UG:B.Pharma - Pharmacy
PG:MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy
Doctorate:Doctorate Not Required
Recruiter Name:Urvesh Majmudar
Contact Company:LUPIN LIMITED
Address :BLOCK NO. 21, DABHASA,PADRA, VADODARA, Gujarat - 391440,India