Piramal Enterprises Ltd. (PEL) is the flagship company of Piramal Group and has a leading position in the business verticals it is present in i.e. Healthcare and Financial Services
We forayed into the health care space in 1988 with a move that was contrarian at that time, as most pharmaceutical players were exiting India due to the existing business climate. It has been 25 years, and we have established ourselves as one of the most recognizable and respected names in the pharmaceutical industry.
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Today, we have manufacturing bases across India, UK, Scotland, the USA, and Canada through subsidiaries. Our critical care products are available in the emergency rooms of hospitals across the globe and our products are available in over 100 countries. We are presently the third-largest player in the global Inhalation Anesthesia (IA) market and the only company in the world with a complete product portfolio of Inhalation Anesthetics drugs.
Our manufacturing capabilities make us one of the largest custom manufacturing companies in the world. The ‘UN Conference on Trade and Development’s World Investment Report 2011’ ranks us among the top 5 in the world.
Through the years, we at Piramal Healthcare have partnered with the largest and most reputed organizations in the global pharmaceutical industry to expand our product offering and deliver the best innovations to our customers.
Position: Manager – Quality Assurance
Location: Ennore Piramal Enterprises Limited, Ernavoor Chennai, Tamil Nadu, India
Job Purpose: Responsible for GMP Compliance and batch release of intermediates and API. Accountable for OOS investigation and approval of analytical method transfer/validation documents of products. Review and approval of facility qualification and co-ordinate failure investigation in Process, calibration, and preventive maintenance activity in both generic and service manufacturing facility.
Role & Responsibilities:
- Strict adherence to cGMP norms and safety rules of the factory
- Liaising with an external manufacturing site for product technology transfer
- Ensure GMP compliance in generic manufacturing & services blocks.
- Batch release of APIs & Intermediates for the market.
- Approval of Out of Specification investigation report related to Generic and service intermediates and API followed by tracking and monitoring of CAPA till closure.
- Responsible for Audit readiness, handling audits, response & closure
- Review and approval of APQR for APIs & Intermediates.
- Conducting the internal & external audits as per GMP/ISO9001 standards.
- To support material management by vendor evaluation and approvals
- Co-ordination with regulatory affairs department for review and approval of change control documents related to processing, facility, equipment related to generics product manufacturing.
- Review and approval of qualification documents related to processing equipment, utility system, facilities, and analytical instruments in QC scheduled as per the Validation Master Plan.
- Investigating deviations related to Process, calibration, preventive maintenance followed by tracking and monitoring of CAPA till closure.
- Review and approval of analytical method transfer and validation documents related to service and generics intermediates and APIs.
- To review and approval of Standard Operating Procedures, Specifications and Test methods in the predefined system
- Review and approval of QMS documents related to Services & generic products such as BMRs, ATPs, change control, deviation, and followed by tracking and monitoring of CAPA till closure.
- Responsible to review pest control management records of the facility.
- Responsible for computer system validation
- Attending customer calls and meetings.
- Data Integrity coordinator (DICO):
- Preparation of site-specific SOP in line with Corporate Guideline on DI.
- Mapping of critical processes to identify DI gaps.
- Compilation of DIRA. Sharing the completed DIRA&DI assessment to Central DICO.
- Preparation of site-specific DI audit schedule.
- Ensure internal audits are performed as per the DI checklist.
- Prepare and share the DI status update for the steering committee review.
- Develop a DI training plan for the site and ensure its execution
- Responsible & Information Technology single point of contact for all ITC initiatives.
- Responsible for any specific task assigned by Head- Quality
- Conducting cGMP training
- In my absence, decision-related to my area of responsibility will be with Head Quality.
Qualification: B.Pharma, M.Pharma
Experience: 10-12 Years