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: Pithampur Piramal Enterprises Limited, Dhar, Madhya Pradesh, India
- To assure & review the quality system and to ensure compliance with established standards.
- Ensure effective implementation of systems and procedures as per cGMP, GLP, ISO 13485, and other regulatory/customer requirements.
- Participate in risk assessment, provide risk-assessment tracking and other established mechanisms for risk assessment.
- Handling of various QMS related software’s like TrackWise, ENSUR, and SAP.
- To represent the QA department in external and internal audits including their compliance and responding to audit observations, customer queries related to QA, and to ensure appropriate corrective actions based on audit findings.
- Participate in Quality Improvement Projects and their implementation.
- To keep a track of quality indicators of the sites of the organization for assessment of quality matrix by the senior management
- To keep a track of the CAPA / action items committed by the audited departments/sites and to ensure that the activities are completed within timeframes.
- To identify gaps and deficiencies at captive sites with respect to corporate and regulatory guidelines and to give insight to senior management.
- Handling of documentation related to self-inspection and to maintain the same as per the procedure.
- Develop reports and analyses to document potential risks and gaps that need corrective action or preventative action.
- To impart training to team members/other concerned personnel/new employees on SOP’s and on the job training.
- To update on regulatory requirements and implementation.
- To review corporate guidelines and policies in order to ensure their adherence to regulatory updates.
- To conduct continuous improvement program throughout the site by continuous auditing of the systems, to monitor and track quality KPI’s
- To initiate change control for changes in documents as per requirements. Participate in a review of Change Controls.
- To Review and Approve QMS like Deviation, Investigations, Change Control, etc.
- To participate in the investigation of complaints related to the quality of products.
- Preparation and handling of MIS, QIP, etc. with site senior team, corporate team, and/or customer on a timely basis.
- Monthly assessment of Warning letter, 483s, and other regulatory observations within the industry.
- Monitoring and implementation of actions related to Data Integrity awareness at the site.
- To ensure data integrity compliances at the site and while performing activities.
Experience: 10-12 Years