Develop and execute operating plans that lead to the achievement of the site and product goals
To ensure manufacturing activities carried out in accordance with applicable GMP and GxP guidelines
Provide direction and leadership for all site operations including but not limited to; Manufacturing, Quality Operations, Materials Management, Technical Services, Engineering, ETP as well as support functions
Communicate effectively with various stakeholders, including but not limited to other areas within the companys supply network, external suppliers, local community, and statutory bodies
Develop and maintain effective relationships with internal and external customers, regulators, and other stakeholders
Develop and maintain an effective organization through effective selection, training, leadership, and management
Support and foster operational excellence across all functions including continuous improvement
Ensure ethics and integrity through compliance / risk management
Create and maintain an environment that encourages teamwork, empowerment and commitment at the site
Lead and support all kinds of regulatory audits relating to the plant
Job Requirements
B Pharm/ M Pharm
At least 17 years experience in pharmaceutical manufacturing including at least 2 3 yearsexperience leading a manufacturing unit/block catering to regulated markets
Should have experience in Semi Solids and OSD formulations, approval from EU and FDA will be an added advantage
Has played a leadership and regulator facing role at least twice in any of the following audits USFDA, TGA, UK MHRA, EU, PICS, MCA etc Up to date knowledge of current GMP related GxP regulations
Demonstrated analytical proficiency
Experience in the latest plant related systems is a plus SAP, LIMs, SCADA, etc Should be currently in the BBN, Punjab, Uttarakhand or Daman area (candidates from other locations with relevant experience who are willing to relocate may be considered)
Should have been part of a greenfield / brownfield project in a lead role
Should have an exposure to Track and Trace Requirements as per Export, EU, US and other Regulatory Requirements