Manager / Sr. Executive – Quality Control

10 - 13 Years
Vadodara

Job Description

  • 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 Benefits 

Salary no bar for deserving candidates

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Role:Quality Assurance/Quality Control Manager

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy, MS/M.Sc(Science) - Any Specialization

Doctorate:Doctorate Not Required

Company Profile

LUPIN LIMITED

Lupin Limited is one of India's largest manufacturers of bulk actives and formulations. The principal bulk actives manufactured by it include Rifampicin, Pyrazinamide, Ethambutol (anti-TB), Cephalosporins (anti-infectives) and cardiovasculars. The company also possesses competencies in phytomedicines, in which medicines are made out of plant and herbal resources supported by the discipline of modern medicine.
View Contact Details+

Recruiter Name:Urvesh Majmudar

Contact Company:LUPIN LIMITED

Telephone:02662-228426

Address :BLOCK NO. 21, DABHASA,PADRA, VADODARA, Gujarat - 391440,India

Website:http://careers.lupin.com/

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