Sun Pharma looking for R&D Quality Senior Executive - B.Pharm, M.Pharm Apply

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : Senior Executive - R&D Quality, CMC QA (Analytical)

Job Description
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.

Candidate Profile
• B.Pharm, M.Pharm
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

Additional Information
Experience : 7-10 years
Qualification : B.Pharm, M.Pharm
Location : Gurgaon
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CMC QA (Analytical)
End Date : 25th October 2025