Executive-Quality Assurance

SUN PHARMA; Mohali; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Sun Pharma in Mohali invites an Executive-Quality Assurance candidate with 7–10 years of experience in pharmaceutical QA to monitor data integrity, review analytical reports, and ensure lab compliance.

The role requires strong CAPA and root cause analysis skills, familiarity with Change Control, SOPs, and instrument calibration, plus training QC analysts. Join us to advance quality and regulatory excellence.

Qualifications

• Educational qualifications include M.Pharm/M.Sc/B.Pharm/B.Sc.
• 7–10 years of experience in pharmaceutical QA
• Knowledge of cGMP and lab compliance

Responsibilities

• Monitor and ensure integrity, accuracy and adequacy of the analysis performed.
• Review analytical reports.
• Ensure Lab Compliance (lab instruments audit trail review, procedural compliance verification, lab rounds and QC activity verification).
• Review Change Control requests, Specifications, SOPs and STPs.
• Periodic verification of application software on computer systems in labs with system administrator.
• Review calibration/Preventive maintenance data for lab instruments.
• Review of OOS/OOT/Out of Calibration/ Lab Events / Deviations / CAPA / Action items.
• Provide support in identification of Root Cause analysis and CAPA.
• Ensure implementation and effectiveness of CAPA.
• Prepare trends of OOS/OOT/Lab Events/QA of QC observations and evaluate CAPA effectiveness for repetitive incidences and train QC analysts.
• Proactively assess quality issues and ensure compliance to defined procedures and regulatory requirements in Quality Control lab.
• Verify data associated with qualification of laboratory instruments.
• Verify data associated with sample destruction.
• Issuance and retrieval / reconciliation of QC hard books, logs, registers and forms.
• Follow EHS policy and cgMP requirements.

Skills

CAPA investigations

Root cause analysis

GMP compliance

Quality control

Education

M.Pharm

M.Sc

B.Pharm

B.Sc

Job description

Job Description:

Job Title: Executive-Quality Assurance

Business Unit: Global Quality and Compliance

Job Grade: G12A

Location: Mohali

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:

• To monitor and ensureintegrity, accuracy and adequacy of the analysis performed.
• Review of analytical reports.
• To ensure Lab Compliance (Lab instruments' audit trail review, procedural compliance verification, Lab round and verification of online QC activities).
• Review of Change Control request, Specification, Standard Test Procedure and SOP.
• Periodic verification of application software on computer systems, associated with laboratory instruments with system administrator.
• Review of lab instruments Calibration/Preventive maintenance data.
• Review of OOS investigation report /Out of trend investigation report/ Out of Calibration report/ Laboratory Event /Deviation / CAPA / Action item.
• To provide support in identification of Root cause analysis and CAPA.
• To ensure implementation and check effectiveness of CAPA.
• To prepare trend of OOS/OOT/Lab Event/QA of QC observation and evaluate the CAPA effectiveness for repetitive incidence and provide technical training to QC analyst.
• Proactively assess quality issues and ensure compliance to the defined procedures and regulatory requirements in Quality Control laboratory.
• Verify data associated with qualification of laboratory instrument.
• Verify data associated with the sample destruction.
• Issuance and retrieval / reconciliation of QC hard book, sequential log, register and forms.
• Follow the EHS policy, laboratory procedures and maintain the compliance to cGMP requirements.

Travel Estimate: Low

Job Requirements:

Educational Qualification: M.Pharm/ M.Sc / B.Pharm / B.Sc

Experience: Tenure: 7 to 10 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).