Manager - DDRC (Quality Technical Agreement & QMS)

Responsibilities

• Conduct compendia assessments for all materials used on-site to identify gaps against current Pharmacopoeial requirements and implement risk mitigation measures to ensure compliance.
• Develop and implement a Standard Operating Procedure (SOP) to ensure process control and long-term sustainability of compendia assessments.
• Collaborate with global sites to gather and analyze data on resource requirements needed for ongoing support of compendia activities.
• Prepare and review Annual Stability Summary Reports in compliance with regulatory and quality requirements.
• Develop and establish Quality Agreements with all relevant vendors and customers, ensuring alignment with regulatory and quality requirements.
• Track and follow up on pending TrackWise CRFs and CAPAs.
• Perform effectiveness checks for closed CAPAs and CRFs.
• Generate and maintain statistics on quality documents (e.g., deviation closures, CRFs, RAs, CAPAs).
• Monitor and track SOP periodic reviews across sites.
• Support SOP updates, including formatting checks and revision history verification.
• Facilitate the creation and routing of CRFs for SOP revisions.
• Prepare and review OOS, OOT, and lab incident investigations; initiate change controls as needed.
• Review planned and unplanned deviations for accuracy, completeness, and cGMP/data integrity compliance.
• Collaborate with site teams to resolve gaps identified during QMS event review and documentation.
• Engage with customers and site teams to ensure timely closure of critical QMS events.
• Route documents through the ENSUR application or other platforms across Piramal plants.
• Participate in customer audits and regulatory inspections, supporting site teams as needed.
• Lead or contribute to additional assignments as directed by the Head of Department (HOD).
  

Qualifications

• Job Identification 8769
• Posting Date 06/25/2025, 10:09 AM
• Apply Before 07/31/2025, 10:09 AM
• Degree Level Bachelor's Degree
• Job Schedule Full time
• Locations Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction,, Mumbai, Maharashtra, 400070, IN