Senior Executive

Job Title Senior Executive - R D Quality CMC QA Analytical Business Unit Global Quality Compliance Job Grade G11B Location Gurugram 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 Key responsibilities Review of R D documents such as stability data Analytical reports Method verification reports Method validation protocols reports analytical data of pilot bio batches DQ batches and Product development data for its adequacy accuracy and completeness as per regulatory and business requirement in order to achieve robust method development and to decrease method failure at site Review of QMS documents like Lab Events Deviations Change control CAPA and associated investigation reports prior to Technology Transfer Support and participate in failure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited R D sites Review facility and equipment qualification documents such as URS DQ IQ OQ PQ related to Analytical Development department and conducting audit for cGxP compliance Responsible to ensure GxP Computerized Systems at R D Gurugram CMC functions site are in compliance with the current regulatory standards Review and support for Computer system Assurance CSA Spreadsheet validation Backups Audit trail review of software and lifecycle documentation for computerized systems Ensure computerized systems consistently meets the required quality standards throughout its lifecycle at R D Gurugram CMC functions site Support on pharmacopoeia updates and new regulations for Analytical Development Department in order to ensure continual improvement in the quality system Visiting the AD Labs Areas for verification of GDP GMP compliance Review of SOPs GQS GSOPs Protocols Reports Standard Test Procedure STP Guideline Review of scale up data process robustness and statistical evaluation technical evaluation for adequacy w r t product development and changes proposed Review and assess data based on QBD based approach to ensure product development data supports to robust product quality through review of documents scientific knowledge Coordinate with cross functional team e g Analytical development Formulation development Site QA QC Project management Regulatory for successful transfer and filling of product Must have strong interpersonal and communication written and spoken English skills Travel Estimate Job Requirements Educational Qualification M Pharm B Pharm Experience Tenure 7-10 years of experience in QC R D Quality involved in Quality assurance Quality control or Analytical development Worked in GMP area and well aware of GMP requirements for investigational medicinal products Good oral and written communication skills Shall be well versed and have experience on quality management system review of method validation method transfer analytical raw data review audit and computer system validation Through understanding of GMP QMS 21 CFR part 11 Annex 11 ICH and WHO Guidelines on Data Integrity reliability and risk assessments Shall be well versed with OOS OOT Investigation Deviation CAPA management 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