| 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 |