Quality Assurance Head-sterile - Cipla Ltd

By: Pharma Jobs | Views: 3135 | Date: 09-Sep-2013

Cipla known for its innovative pharmaceutical products backed by latest in technology and creative marketing practices, is enjoying a commanding position among the top pharma companies in the country.


Quality Assurance Head-Sterile - Cipla Ltd

Cipla known for its innovative pharmaceutical products backed by latest in technology and creative marketing practices, is enjoying a commanding position among the top pharma companies in the country.



Several specialised therapeutic divisions and promising new products have been launched and many more are in the pipeline.
Designation Quality Assurance Head-sterile
Job Description
  •  Overall responsibility of Quality Assurance Department.
  • Support and advise the root cause investigation team in the determination of root cause and identification of effective CAPA.
  • Improvement, continuous review and upgrading of existing SOPs, specifications, test methods and work systems including risk assessment with respect to current guidelines.
  • Responsible for assuring that all the requirements of annual product quality review are fulfilled and to approve the APQR.
  • Ensure investigation of out-of-specification, out-of-trend, process and procedure deviation, discrepancies, test failures and batch failures are appropriately performed and documented.
  • Approval / rejection / discard / obsolete of formulation code, manufacturing code, batch number and batch issue requests in production system.
  • Creation and maintenance of unit masters like department master, caution master and year master in production system.
  • Continual improvement of the quality system.
  • Monitoring of compliance with the requirements of Current Good Manufacturing practices and GMP requirements of country where product is being exported.
  • Approval/disapproval, close out of deviation.
  • Identification of training needs and competency matrix.
  • To ensure timely and effective communication to senior management.

Desired Profile
  •  Should have direct exposure to regulatory audits viz USFDA, MHRA, TGA Etc,
  • Must Possess an Excellent communication Skills
  • Must have good leadership Skills
Experience 10 - 20 Years
Industry Type Pharma / Biotech / Clinical Research
Role Quality Assurance/Quality Control Manager
Functional Area Production, Manufacturing, Maintenance
Education UG - Any Graduate - Any Specialization, Graduation Not Required
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required
DOCTORATE - Any Doctorate - Any Specialization, Doctorate Not Required
Location Indore
Keywords Excellent communication, exposure to regulatory audits, leadership Skills
Contact Cipla HR Team
Cipla Ltd
Job Posted 26 Aug
Reference 000QA Sterile

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