Senior QC Microbiology Lab Operations Manager

Sun Pharmaceutical Industries, Inc.

Indiana (PA)

On-site

USD 110,000 - 150,000

Full time

14 days+

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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.