Title:  Senior Executive - QUALITY ASSURANCE

Job Title:

Sr. Executive   – Analytical Doc. Review, QMS Activities

Business Unit:

Global Quality & Compliance

Job Grade

G11B

Location :

Dahej

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 Finished API, Raw material, Intermediate, In-process, stability analysis and documentation.
• Review all the Analytical documents and Micro related documents.
• Review of the QC system / procedures / SOP and finding gaps between practice and system SOP’s during QC Lab rounds and periodic review of SOP.
• Review of the OOS, OOC, OOT and Lab event investigation reports. Review of the OOS, OOC, OOT and Lab event investigation reports.
• To review instrument usage Log books of instruments and HPLC column issuance log books.
• Document review of calibration and preventive maintenance of analytical instruments.
• Responsible for initiation and investigation of OOS, OOT and Lab events and its documentation.
• To ensure trending of OOS/ OOT / Lab events
• Review and Approval of the Audit trails of the chromatographic and non-chromatographic system.
• To ensure the trending of analyst errors based on review of analytical data & accordingly training to be imparted.
• Audit trial review & if any abnormalities observed then same to be reported to Head QC/ Head QA / Head Quality.
• Involve in the investigation of the OOS / OOC / Lab event / UPD / correctness of Hypothesis performed as per predefined protocol, to identify the root cause. Correctness of Impact analysis, Correctness of Risk assessment, Verification & implementation of CAPA.
• On job training to analyst, share the lab event / Incident to analyst to avoid the reoccurrence.
• Preparation of departmental SOPs and review of other departmental SOPs.
• Other Quality departmental activity allotted by department head or designee for cGMP compliance
• Other activities instructed from time to time.

Travel Estimate

Low

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure:  9 to 12 Years  

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).