Job Title Manager Sr Manager - API Cluster Support QA Business Unit Global Quality Compliance Job Grade G10 G9B Location Mumbai 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 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 Travel Estimate 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 chance to grow collaborate and make a lasting impact Let s create a brighter future together Disclaimer The preceding 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

📌 Manager / Sr.manager - Api Cluster Support (qa) (Mumbai)
🏢 Sun Pharmaceutical Industries
📍 Mumbai