
Senior Executive
1 day ago
Job Description
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).
-
Deputy Manager – IT/IS
2 weeks ago
Gurugram, India Senior Full timeCompany Description Senior is a UK based MNC and has operations in 12 countries and has 26 operating businesses worldwide serving number of markets. Senior's experienced manpower support, effective use of raw material as well as high technology enable it to deliver optimized components within a short development time and at most competitive prices. Senior...
-
Senior Executive/ Assistant Manager
2 weeks ago
Gurugram, India Executive Search Full timeRequired skills/qualifications: 1) Knowledge and experience in B-to-B Audio marketing 2) Data analysis skills 3) Communication and presentation skills 4) Planning and execution skills Scope of responsibility: Responsible for the success of the marketing strategy Personality sought: 1) Willingness to deliver results 2) Problem-solving skills 3) Teamwork...
-
Executive/ Senior Executive
2 weeks ago
Gurugram, Gurugram, India AGRIM Full timeJob Description Agrim is a B2B e-commerce marketplace dealing in agri-inputs. We are currently hiring for Senior Sales Executive and below are the requirements- - Proven sales experience. - Excellent negotiation and consultative sales skills. - Effective communication skills. - Exceptional customer service skills. - Agriculture background will be...
-
Senior Operations Executive
1 day ago
Gurugram, Gurugram, India Tagglabs Full timeJob Description Job Description: Senior Operations Executive Location: Gurgaon Department: Operations Reports To: Head of Operations Pay: Negotiable About Tagglabs Tagglabs is a creative technology studio that blends design, strategy, and innovation to craft immersive brand experiences. From spatial design to digital products, we create interactive,...
-
Senior Finance Executive
2 weeks ago
Gurugram, Gurugram, India Rrayze Business Solutions Full timeJob Description Job Title: Senior Account Executive Location: Gurgaon Experience: 2+ Years Job Summary: We are looking for a motivated and detail-oriented Senior Account Executive to join our finance team in Gurgaon. The ideal candidate will be responsible for managing key accounting functions, vendor reconciliation, related party reconciliation, and...
-
Executive Assistant
2 days ago
Bengaluru, Gurugram, Mumbai, India Executive Search Full time ₹ 9,00,000 - ₹ 12,00,000 per yearRole & responsibilitiesManage calendars and schedules for 3-4 senior leaders across time zonesOrganize domestic and international travel; handle visa applications (Schengen, US, UK)Ensure timely and accurate submission of expenses and timesheetsProvide logistical and technical support for meetings and workshopsBuild strong internal and external stakeholder...
-
Senior Executive
2 weeks ago
Gurugram, India Flyorbit Full timeJob Description We're Hiring! Position: Senior Executive Operations Company: Flyorbit by SR India Voyages Pvt Ltd Location: Delhi NCR Experience Required: Minimum 2 Years in the Travel Industry About Us: Flyorbit by SR India Voyages Pvt Ltd Founded in 2009, SR India Voyages has grown into one of Delhi & Gurgaon's premier travel operators, admired for...
-
Senior Java Developer
2 weeks ago
Gurugram, India EDGE Executive Search Full timeThe Company Our client is a global company in the fintech sector, a global giant in the derivatives space and second, a world leader in financial research and analytics.This company will work in the area of derivatives and OTC products, which are the most complex parts of the financial market. The company is laying the foundations of a great culture and...
-
Sr. Designer
2 weeks ago
Gurugram, India Ally-eXecutive HR Full timeRole:Senior Designer- Workplace About the job We are seeking a new Senior Designer- Workplace. You will be part of our design studio designing Corporate / Workplace Interior projects. Working closely with the design leaders and team, you will be responsible for developing design concepts for corporate interior fit out projects. In Brief Specific...
-
Senior Program Counsellor
2 weeks ago
Mumbai, India Imarticus Executive Education Full timeJob Description Role Description This is a full-time on-site role for a Senior Program Counsellor located in Mumbai. The Senior Program Counsellor will be responsible for guiding students through the enrollment process, providing information about programs. Preferred Immediate Joiner Experience-1 to 7 Years in Edtech Sales CTC Upto 7 LPA Key Skills...