Piramal Enterprises Limited
247 Business Park,
A – Wing, 6th Floor
LBS Marg, Vikhroli (West)
In the late 1980s, we moved from textile to pharmaceuticals. While others were keen over international generics, we invested in the domestic formulation development business. Our efforts soon bore returns as we have had a track record of approx. 23% revenue CAGR since then. In 2010, it completed sale of its domestic formulations business an unprecedented value of ~9x sales and ~30x EBITDA. In May 2013, Piramal Enterprises Ltd. acquired 10% equity stake in Shriram Transport Finance. Later in April 2014, we acquired 20% equity stake in Shriram Capital Limited, a financial services company and in June 2014, 9.9% stake in Shriram City Union Finance Limited, the retail focused Non-banking Financial Company (NBFC) of the Shriram Group.
Job Title : Chief Manager – QA
Business : Piramal Healthcare
Function : Quality
Location : Mahad, India
Purpose of Job:
- Establish, document and implement quality management system, and to ensure effective implementation, monitoring and control of quality management system.
Role directly reports to
- General Manager-Quality Assurance
- Bachelors in Pharmacy
- 10 to 15 years of experience in Pharma industry.
- Establish, document and implement quality management system, and to ensure effective implementation, monitoring and control of quality management system at manufacturing , packing, testing and warehouse activities with respect to laid down procedures, systems and identify areas for improvement.
- Approve validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers.
- Approve SOPs, batch manufacturing and packing records, specifications and test methods of the products.
- Monitor, control and approve deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution.
- Ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guide lines as per quality management system.
- Ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program.
- Ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically.
- Evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures , that each production batch complies with the provisions of Drugs and Cosmetics Act and other legal, customer and regulatory requirements.
- Ensure compliance to the regulatory, customer, legal requirements and face audits and comply non conformities observed during the audits.
- Ensure compliance to the current ISO 9000, ISO 14000, D&C Act, PFA Act, NDPS , HACCP , SQF, WHO-GMP, UNICEF and other customer and regulatory requirements.
- Carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility.
- Ensure completion of APRs of products and take appropriate actions in case of deviations.
- Recommendation to recall approving authority on product recall, review and disposition of recalled and returned goods.
- Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition.
- Co-ordinate with CQA for upgradation in the SAP systems as per any changes or new product at Mahad site.
- Monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures.
- Monitor the conformance of the site (Local) documents, with the master dossiers (Technical Registration Dossiers) of products.
- Identify and provide resources with co-ordination with other departments to carry out quality functions effectively.
- Liaison with regulatory authority for new product permissions, licenses and renewals, certificates and approvals
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