Senior manager - R&D QA

Senior manager - R&D QA

Responsibilities:

• Lead and manage R & D-QA function with subordinates reporting.
• Ensure quality by design in the activities of R&D.
• Driving first-time-right approach & striving to achieve zero defects in document adherence & accuracy.
• Overseeing RM, PM, SFG, FG-specification, SOPs, STPs, GTPs etc. development.
• Implementation of sound and up-to-date principles of GLP, cGMP and other industrial practices.
• Spearhead documentation processes, technology transfer documentation, regulatory support to queries.
• Independently evaluate analytical practices, limitations and plan risk mitigation plan with ADL & FD teams.
• Develop quality evaluation parameters with CFTs for RM and FG.
• Work with global and local regulatory teams for ensuring product and process compliances during R & D development.
• Spearhead technology transfer documentation and deployment to various locations
• Prepare and submit relevant technical documents to the business hubs/centers
• Executing and monitoring of Stability studies as per protocol-includes withdrawal & submission for analysis;
• Compilation of stability results and update OOS/OOT to the concerned FD
• Manage troubleshooting related to quality and relevant communications within HGRC
• Auditing labs, notebooks and data management including deviations, CAPA etc.
• Addressing manufacturing concerns, failures, participation in RCA and CAPA implementation with site QA
• Troubleshoot issues related to quality by bringing all stakeholders as needed and providing quick solution for minimal business impact.

Qualifications

• Masters in Pharmacy or equivalent
• Min 15 years demonstrated experience in R & D quality assurance function.
• Prior experience in handling products under Pharma, Personal care and dietary supplements with sound knowledge of global practices and regulatory requirements.
• Experience of managing direct reports and collaborations globally with diverse teams
• In-depth understanding of analytical practices

Skills:

• Agile & pragmatic approach balancing business expectations with quality needs.
• Team orientation, “can-do “attitude and ability to deliver breakthrough results
• Art of negotiations, creative, follow-through -desired traits
• Ability to set up clear objective and priority-setting
• Knowledge of digital tools/processes/systems
• Proficient in written and oral communication in English