Manager / Sr.Manager – API Cluster Support (QA)

Designation : Manager

Function : Quality Assurance

Functional Area : QA API

Job Role Summary : The Senior Manager – API Cluster Support is responsible for ensuring compliance with cGMPs and GLPs across all API manufacturing sites. 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.  

Job Profile :

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

Job Requirements :

Experience
Tenure:  14+ years

Work / Job Experience : 14+ Years

Type of Experience : QA

Academic Qualifications :

B.Pharm / M.Pharm

Job Post Link : https://tinyurl.com/yuhyjvt8