Manager Micro (Lab Ops)

Sun Pharmaceutical Industries, Inc.; Indiana (PA); On-site; USD 110,000 - 150,000; Full time

Job summary

Sun Pharma in the Global Quality & Compliance unit seeks a Micro (Lab Ops) to oversee QC Microbiology activities, ensuring compliance and productivity in line with management expectations. You will review documents in Trackwise, approve SOPs, and coordinate sampling, analysis, and reporting for Micro, collaborating with cross-functional teams to drive quality and regulatory readiness.

This role requires leadership, meticulous documentation, and proactive CAPA handling to prevent deviations and

Qualifications

• Oversee all activities related to QC Microbiology.
• Ensure compliance in QC Microbiology.
• Ensure Productivity and service level as defined by management for all QC Microbiology.
• Review / approve all documents related to QC Microbiology in Trackwise.
• Review SOP related to QC Microbiology.
• Approval of master ATP and specification in LMS.
• Plan for sampling, analysis and report preparation related to Micro.
• Approve the indent for materials required for QC Micro.
• Review URS, DQ, SAT, FAT area start up and equipment / instrument qualification protocol related to QC Micro and cross functional department.
• Review and approve BET validation and sterility validation protocol and report.
• Closure of Investigation like OOS, OOC, repeat, event, incident, CAPA, etc.
• Provide response and ensure compliance of internal audit and regulatory audit observations related to QC Micro.
• Review / approve other protocols of cross function team.

Responsibilities

• To oversee all activities related to QC Microbiology.
• To ensure compliance in QC Microbiology.
• To ensure Productivity and service level as defined by management for all QC Microbiology.
• To review / approve all documents related to QC Microbiology in Trackwise.
• To review SOP related to QC Microbiology.
• Approval of master ATP and specification in LMS.
• To plan for sampling, analysis and report preparation related to Micro.
• To approve the indent for materials required for QC Micro.
• To review URS, DQ, SAT, FAT area start up and equipment / instrument qualification protocol related to QC Micro and cross functional department.
• To review and approve BET validation and sterility validation protocol and report.
• Closure of Investigation like OOS, OOC, repeat, event, incident, CAPA, etc.
• To provide response and ensure compliance of internal audit and regulatory audit observations related to QC Micro.
• To review / approve other protocols of cross function team.

Education

M.Sc. (Microbiology)

Tools

Trackwise

LMS

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Micro (Lab Ops)

Business Unit:

Global Quality & Compliance

Job Grade

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 oversee all activities related to QC Microbiology.
• To ensure compliance in QC Microbiology.
• To ensure Productivity and service level as defined by management for all QC Microbiology.
• To review / approve all documents related to QC Microbiology in Trackwise.
• To review SOP related to QC Microbiology.
• Approval of master ATP and specification in LMS.
• To plan for sampling, analysis and report preparation related to Micro.
• To approve the indent for materials required for QC Micro.
• To review URS, DQ, SAT, FAT area start up and equipment / instrument qualification protocol related to QC Micro and cross functional department.
• To review and approve BET validation and sterility validation protocol and report.
• Closure of Investigation like OOS, OOC, repeat, event, incident, CAPA, etc.
• To provide response and ensure compliance of internal audit and regulatory audit observations related to QC Micro.
• To review / approve other protocols of cross function team.

Job Requirements

Educational Qualification

M.Sc. (Microbiology)

Experience

Tenure : 13-15 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).