Head - Quality Assurance - Sterile Product

Position: Head Quality Assurance- Sterile Products

Location: Ahmedabad

Experience: 20+ Years

Reporting to: SVP

Responsibilities:

- Having 20 years of experience in pharmaceutical industry and acting as site QA Head or second line since last 3 years for Injectable dosage form

- Must have sound knowledge of Aseptic Product Processes/ Products manufactured as Terminally sterilised/ Lyophilised Products/ NNDS Platform

- Must be well versed with current regulatory requirements for Sterile Products

- To ensure overall compliance of cGMP/GLP practices at plant.

- Ensure that all the in-process QA activities carried out as per the requirement and resolve day to day operational related issues.

- Harmonization of Quality Management system across other sites.

- Establishing effective Quality systems, standards & cGMP procedure at site.

- Authorize all master documents viz. SOP, Master Production/Packing Control Records,

- Validation/ Qualification Protocols and Reports, Standard Testing Procedure, Annual Product review.

- Review Reports, Analytical Method Transfer Reports etc. and relevant formats.

- Effective adherence to the training system to ensure GMP/GXP activities are performed by

trained and qualified persons.

- Training, Self-Inspection etc. and monitoring of the adherence of the schedule.

- Ensure successful regulatory inspection and timely closure of regulatory commitments.

- Ensure good documentation practices followed as per ALCOA+ principle to paper and electronic records

- Ensure adherence of Data Integrity Policy.

- Hands on experience on review and approval of QMS elements viz. Change Controls, Deviation, Investigation, CAPA . Market complaint and Product Recall

- Ensure effective corrective / preventive actions are implemented at site.

- Effectively and timely closure of market complaints, OOS, OOT and other QMS elements.

- Ensure to provide technical support and timely submission of documents to regulatory.

- To ensure electronic software implementation

- Responsible for Batch Release

- Responsible to initiate and coordinate the Management Review Meeting at site and escalate the potential issues to senior management.

- Review and approval of technical agreements.

- Hands on exposure on 21 CFR part 11 / EU GMP Annexure -11 requirement for process equipment qualification / Lab instrument.

- Ensure compliance of process validation, cleaning validation and equipment / utility qualification including media fill and smoke study. Ensure that the processes and system remains in a state of validation and compliance.

- QA oversight in QC activities

- Hands on experience on various regulatory audits i.e. USFDA, MHRA / EMA , ANVISA , TGA etc.