Senior Manager - Cluster Support (API)

Sun Pharmaceutical Industries, Inc.; Mumbai; On-site; INR 1,500,000 - 2,000,000; Full time

Benefits offered by this job

Robust benefits for personal and professional growth

Supportive community

Opportunities for continuous progress

Job summary

Sun Pharmaceutical Industries, Inc. seeks a Senior Manager for API Cluster Support in Mumbai. This role ensures compliance with cGMPs and GLPs at all API manufacturing sites, requiring extensive experience in API quality control and regulatory audits.

Ideal candidates will have a B.Pharm or M.Pharm degree and over 14 years of relevant experience, demonstrating leadership in improving quality systems and supporting audits. Join Sun Pharma to grow in a supportive environment.

Qualifications

• 14+ years of relevant experience in Quality Control and Compliance.
• Expert in cGMPs and GLPs across API manufacturing.
• Proven track record in managing regulatory audits and compliance.

Responsibilities

• Monitor compliance with cGMPs, GLPs, and regulatory requirements across API sites.
• Coordinate quality improvement efforts across API sites.
• Support internal and external audits, including remediation plan execution.

Skills

cGMPs Compliance

Quality Control Investigations

Regulatory Audit Support

Process Improvements

Education

B.Pharm / M.Pharm

Tools

Laboratory IT systems

QMS Software

Job description

Select how often (in days) to receive an alert: Create Alert

Location: Tandalja - R&D

Company: Sun Pharmaceutical Industries Ltd

Job Title:

Business Unit:

Global Quality & Compliance

Job Grade

G9A

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.”

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 :

• 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.

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).
• 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 elevate 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

Job Requirements

Educational Qualification

B.Pharm / M.Pharm

Experience

Tenure: 14+ 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).