Senior Manager – API Cluster Support

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Job Summary:

The Senior Manager – API Cluster Support is responsible for ensuring compliance with cGMPs and GLPs across all API manufacturing sites. The person shall have experience in API QC & QA background, which includes exposure in handling of production manufacturing investigations, computer system validations expertism, and also exposure to Quality Control experience, taking care of all QC investigations. This role involves monitoring and improving quality systems, facilitating quality management reviews, and driving continuous improvement initiatives. The position also supports regulatory audits, coordinates corrective actions, and addresses critical quality issues to maintain operational excellence and regulatory compliance.

Key Responsibilities:

Ensure Compliance and Quality Oversight

• Vendor Management
• Monitor compliance with cGMPs, GLPs, and regulatory requirements across API sites.
• Resolve escalated quality issues and support corrective actions and process improvements.
• Conduct weekly calls to track compliance actions from regulatory inspections and internal/customer audits, cascading learnings across sites.
• Coordinate with R&D to track pending actions related to Nitrosamine assessment, Genotoxic assessment, Cleaning methods (HPLC vs. UV), UV absorbance methods, and Method validations (KSM, intermediates).
• Ensure completeness and reassessment of nitrosamine and genotoxic data as per current regulatory expectations.
• Vendor Management

QMS Extension Optimization

• Monitor and track QMS performance to optimize extension.

Quality Management Reviews

• Participate in site and corporate QMRs.
• Collect and summarize cluster-level data for management review meetings.
• Implement improvements to standardize processes across API sites.

Global Standards & Harmonization

• Align site procedures with global quality standards and corporate policies (GQS and GSOP Implementation).

Continuous Improvement Initiatives

• Lead initiatives to enhance compliance, efficiency, and cost-effectiveness.

Regulatory Audit Support

• Support internal and external audits, including remediation plan execution.
• Coordinate audit responses and ensure effective resolution of observations.

Metrics Monitoring & Reporting

• Track QA/QC metrics and ensure timely action on deviations.

Gap Analysis & Process Improvements

• Conduct gap analyses and implement strategies to close gaps and improve system performance.

Industry Trend Monitoring

• Stay updated on regulatory changes and industry trends to identify improvement opportunities.

Site Coordination for Global Action Implementation

• Coordinate quality improvement efforts across API sites to ensure consistent implementation of global actions.

Compliance Monitoring & QMS Oversight

• Continuously monitor and track site QMS pendency and LIMS template pendency to proactively prevent regulatory or internal audit observations.
• Timely escalate long-pending QMS records and support site teams to ensure closure within defined timelines.

Alignment with Quality IT

• Ensure close collaboration with the Quality IT team to support CFR Part 11 and Annex 11 compliance across all applicable systems.
• Ensure compliance of laboratory IT systems such as Empower, LabX, and LabSolution with enterprise-level requirements.

Laboratory Compliance

• Ensure robust oversight and compliance in key laboratory areas, including:
• Unconfirmed OOS investigations
• Laboratory events and deviations
• Method validation for analytical procedures
• Cleaning validation including analytical methods and alignment with GSOP and GQS requirements
• Implementation of GSOPs and GQS standards across laboratory operations
• Monitoring OTIF (On-Time In-Full) and SLA (Service Level Agreements) to ensure timely and quality deliverables

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure : 15 to 17 Yrs

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