Job Title
Senior Executive – R&D Quality, CMC QA (Analytical)
Business Unit
Global Quality & Compliance
Job Grade
G11B
Location :
GurugramAt 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).
