Officer-Microbiologist

Sun Pharmaceutical Industries, Inc.; Mohali; On-site; INR 500,000 - 900,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Mohali invites an Officer-Microbiologist to join Global Quality and Compliance. The role focuses on monitoring microbiology analyses, reviewing data, calibration, OOS/OOT investigations, and ensuring lab compliance.

You will participate in audits, change control, and regulatory data submissions, while upholding Sun Pharma's values and striving for continuous improvement.

Responsibilities

• To monitor and ensure integrity, accuracy and adequacy of the analysis performed.
• To perform second person results verification activity for all microbial test results (e.g. agar plate/ broth media container).
• Review of chemical and micro water Analytical Data, Certificate of Analysis and Related Documents.
• Review of environmental monitoring and Swab Analysis Analytical Data, Certificate of Analysis and Related Documents.
• Review of Raw Material/ Packaging Material/ Stability/ Microbiology / Cleaning Method Validation/ Finished Product Analytical Data, Certificate of Analysis and Related Documents.
• Review of daily calibration and verification of instruments/equipment Analytical Data, Certificate of Analysis and Related Documents.

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Officer-Microbiologist

Business Unit:

Global Quality and Compliance

Job Grade:

G12C

Location:

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.
• To perform second person results verification activity for all microbial test results (e. g. agar plate/ broth media container).
• Review of chemical and micro water Analytical Data, Certificate of Analysis and Related Documents.
• Review of environmental monitoring and Swab Analysis Analytical Data, Certificate of Analysis and Related Documents.
• Review of Raw Material/ Packaging Material/ Stability/ Microbiology / Cleaning Method Validation/ Finished Product Analytical Data, Certificate of Analysis and Related Documents.
• Review of daily calibration and verification of instruments/equipment Analytical Data, Certificate of Analysis and Related Documents.
• Review and approval of additional testing requests (if required)
• Participation in handling OOS, OOT, and Investigation & Deviations related to Quality Control.
• Review and approval of Weekly, Monthly software verification reports of Empower3.
• 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 Certificate of Analysis (COA).
• Review and submission of analytical data to site regulatory affairs.
• To provide the response of regulatory affairs and Office of Data Reliability queries.
• Review and approval of change control request, specification, standard test procedure & SOP in Document Compliance Manager System.
• To conduct laboratory visit, to oversee the lab compliance and to rectify the gaps identified.
• Perform all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Perform all work in accordance with all established regulatory and compliance and safety requirements.
• To participate in all internal/external audits.
• To perform Gap Assessment for Pharmacopeial changes as per USP and Ph. Eur. and to ensure compliance as per SOP.

Low

Job Requirements

Educational Qualification

Experience

Tenure : 2 to 4years

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).