Job Description

Department Details

Role Summary

Having hands on work experience in equipment qualification, CSV and engineering specialist,

Should have worked in pharmaceutical company, having approvals from regulated markets like USFDA, EMA, PMDA, PICs and ANVISA etc.

Key Responsibilities

Primary responsibilities:
1. Providing QA oversight for all commissioning, qualification and Engineering aspects, at site 1 - Biocon Biologics facility (includes manufacturing, utilities, water plant, warehouse and quality control facilities).
2. Monitoring of commissioning and qualifications (FAT/SAT/IQ/OQ/IOQ/PQ/RQ) of instrument, equipment, facility and utilities. Reviewing of ongoing qualification, which complies to internal SOPs.
3. Review and approval of documents related to Commissioning and Qualification (URS to PQ/RQ), SOPs for instrument / equipment / utility operation and Engineering SOP's, as applicable. Support development of SOPs.
4. Review and approval of CSV documents and support development of SOPs, as applicable.
5. Preparation / Review of Standard Operating Procedures relevant to Engineering QA and to impart training (Including General Training relevant to Engineering QA).
6. Define requirement of planners. Review and approval of planners (Calibration, Preventive Maintenance, data back up, RQ so on) and ensuring all the activities are performed as per the defined planner.
7. Reviewing and approval of QMS documents like Change Controls, Events, OOS and Risk Assessment related to Instrument / Equipment / Utility Performance (breakdowns, excursion etc.) and facility, as applicable.
8. Review and approval of facility, utility and equipment layouts / drawings so on.
9. Preparation / Review / Approval (As applicable) of Facility Performance Review document.
10. Handling of breakdown reports / documents.
11. Support / implement all the activities that are taken-up to enhance the facility and systems, as per regulatory requirements.
12. Providing QA oversight on risk assessments of new introduction / modification of areas / instrument / equipment / facility / software / utility so on and inspection to check compliance (engineering relevant aspects) to cGMP / cGEP at regular intervals.

Educational Qualifications

Required Education Qualification: B.E
Required Experience: 6 - 9 years