Quality Assurance

Job Description:

Quality Assurance - Associate

The Quality Assurance - Associate is responsible for managing R&D quality assurance activities for pharmaceutical and personal care new product development. The role focuses on ensuring quality by design, compliance with applicable regulatory and quality standards, effective documentation, analytical evaluation, stability management, and cross‑functional collaboration to support compliant and efficient R&D development activities.

• Manage routine R&D-QA activities independently for pharma and CPD NPDs.
• Ensure quality by design in the activities of R&D.
• Oversee the development of RM, PM, SFG, Bulk, FG-specification, SOPs, STPs, GTPs, etc.
• Implement sound and up-to-date principles of GLP, CGMP, and other industrial practices.
• Spearhead documentation processes, technology transfer, and regulatory support to queries.
• Independently evaluate analytical practices, limitations, and plan risk mitigation with ADL and FD teams.
• Work with global and local regulatory teams to ensure product and process compliance during R&D development.
• Prepare and submit relevant technical documents to the business hubs/centers.
• Execute and monitor stability studies as per protocol, including withdrawal and submission for analysis.
• Compile stability results and update OOS/OOT to the concerned FD.
• Manage troubleshooting related to quality and relevant communications within HGRC.
• Audit labs, notebooks, and data management, including deviations, CAPA, etc.
• Support in addressing manufacturing concerns, failures, and participation in RCA and CAPA implementation.

Bachelor in Pharmacy or Science with a minimum of 1-3 years demonstrated experience in R&D quality assurance functions, specifically in handling global personal care, OTC, or pharmaceutical products.

• Strong can-do attitude, business mindset, sense of urgency, risk-taking approach, and influencing skills.
• Experience as a team member, with a background in managing and collaborating globally with diverse teams.
• In-depth understanding of analytical practices.
• Experience working with multiethnic, multicultural societies to understand and respect diversity and accommodate expectations for a global delivery platform.
• In-depth knowledge of FDA, ISO 22716, and ISO 9001:2015 QMS guidelines.