[Urgent] Site Quality Head

Job Title Site Quality Head - API Business Unit Global Quality And Compliance Job Grade G6 - Senior General Manager Location Ahmednagar Key Responsibilities At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys Position Summary - Ensure the supply of high quality GMP compliant products define operational strategy for quality system management at site finalize site quality assurance and quality control goals objectives and strategies in line with Sun Pharma compliance product quality management objectives and regulatory requirements Provide leadership and direction to ensure achievement of all site accountabilities for QA QC and Stability at site Proactively assess quality issues at site and ensure compliance to QA QC regulatory requirements in manufacturing operations at the site and track quality assurance control metrics with site manufacturing and drive them down Assure all time readiness of site for regulatory agency inspectionsinternal audits at any given point The incumbent will assure individual compliance with the all concerned regulatory requirements GxP s and applicable department programs including training documentation Standard Operating Procedures and Sun Pharma Global Quality Policies Standards and Procedures Key responsibilities 1 Assess quality issues at site and ensure compliance to QA QC regulatory requirements in manufacturing operations at site and track quality metrics with site manufacturing management and drive them down 2 Accountable for designing implementing and ensuring compliance to all quality related SOPs Policies Standards and Quality systems at the site 3 Design and execute continuous improvement initiatives at the site to enhance compliance drive efficiencies and cost effectiveness 4 Responsible for ensuring availability of adequate resources including manpower to maintain compliance with GXP requirements 5 Facilitate harmonization and consistent implementation of Quality Systems and procedures at site in alignment with Global Quality policiesstandards 6 Ensure market complaints failures deviations are investigated and corrective and preventive actions are implemented with adherence to timelines 1 Assure all time readiness of site for regulatory agency inspectionsinternal audits and appropriate implementation of corrective actions regarding observations made by the agenciesinternal audit teams 2 Monitor industry trends issues faced internally and identify scope for improving Site quality management and processes 3 Ensure compliance to regulatory requirements on product process and release procedures 4 Prepare site quality revenue and capital budgets and headcount projections track and manage expenditures and headcount to budget over the fiscal year 5 Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment 6 Responsible for ensuring smooth collaboration with all Sun Pharma sites and functions to leverage synergies 7 Follow the EHS policy laboratory standard operating procedures and maintain the compliance to GMP requirements Travel Estimate Low Job Requirements Educational Qualification B Pharm M Pharm Experience Tenure 20 to 22 Yrs Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees as assigned to this job Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent s