Salary Range: 10 - 20 LPA

B. Pharma, M. Pharma or M.Sc. with 8-15 years of experience in CQA functions like QMS, Validations, Qualifications, Analytical Assurance and Mfg. Assurance etc.- (Personnel from Production, Engineering and QC can also apply.

1) Process and Cleaning Validation:

- Independently responsible for all Process validation related activity including ANDA batches (Pre-exhibit and exhibit batches) like preparation, execution and closing of validation protocol with complete compilation along with all reports, following proper change control procedure to provide information regarding revision in Documents, Preparation and completion of hold time protocol etc. )

- Preparation of Master validation protocol and report for all regulated as well as non regulated market.

- Preparation of Hold time study protocol and report.

- Preparation of Process variable impact analysis.

- Preparation of Failure mode effect analysis.

- Submission of all validation documents to various regulatory bodies as per respective regulatory requirement.

- Establishment of worst case for cleaning validation.

- Preparation of individual equipment and identical equipment chain to verify the worst case product.

- Acceptance criteria and surface area calculation.

- Various study relating to cleaning validation.

2) Qualification:

- Preparation and review of URS.

- Review of Design Qualification in line with User requirement Specification

- Preparation, Execution and compilation of Equipment Qualification.

- Review of operation, Cleaning and Preventive Maintenance SOP.

- Preparation, Review and execution of AHU Qualification / HVAC system document.

- Review of layout.

- Preparation and Updation of validation master plan & Project VMP.

- Preparation and execution of Visual inspector Qualification.

- Preparation, Execution and compilation of water system.

- Ensure that appropriate calibration and preventive maintenance of manufacturing equipment's and laboratory instruments are conducted as schedule.

3) Technology Transfer Activities:

- Preparation of MMF, BMR, BOM, PFS.

- Formula and Batch size comparison of sender unit and receiving unit.

- Equipment comparison between sender unit and receiving unit followed by equipment equivalency and verification study.

- FPS and FPSS comparison between sender unit and receiving unit.

- Preparation of process flow sheet.

- In process data comparison between sender unit and receiving unit.

- Analytical result comparison between sender unit and receiving unit.

- Preparation of technology transfer report.

- Execution of batches with consultation of R&D at manufacturing unit.

4) Quality Management System:

- Generation, approval and issuance of batch documents, validation protocol / reports, written procedure including amendments and control of their soft and hard copies.

- To monitor retention and destruction of records.

- Investigation of recall products / complaints.

- Conduct the self inspection and / or quality audit that regularly appraise the effectiveness and applicability of the quality assurance system.

- Ensure investigation of deviation / Out of trends / Out of specification and batch failure are appropriately performed and documented.

- Perform annual review of all drug products to assure that quality standards are appropriate and recommended action if any.

- Conducting and review of unit operation.

- Ensure appropriate corrective and preventive action (CAPA) based on the result of investigation are identified and implemented.

- Approval of stability testing form and stability summary report.

- Handling of change control and deviation, Investigation reports, CAPA logging.

- Preparation of SOPs.

- Assist with market complain

- Preparation of APQR with trend analysis.

- Responsible for Batch release.

- Batch failure investigation.

- Identification of training needs and imparting training with respect to cGMP, Safety, application and principles of Quality assurance.

- Ensure that the required initial and continuing training of department personnel are carried out and adopted according to the need.

5) IPQA Activities:

- In-process Quality Control.

- Line clearance of all the production activity.

- To keep sharp check over all the production activity.

- To keep sharp attention on Dispensing as per SOP.

- Review of draft documents like BMR, MMF, and PPS etc.

- Training to shop floor team with respect to cGMP.

- Reviewing of executed production documents.

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