Overview
Development Quality Assurance Manager Jobs in Pune/Pimpri-Chinchwad Area at Innovassynth
Title: Development Quality Assurance Manager
Company: Innovassynth
Location: Pune/Pimpri-Chinchwad Area
The Deputy Manager – Development Quality Assurance will be responsible for overseeing Quality Assurance for R&D and development activities, ensuring compliance with internal quality systems, customer requirements, and applicable regulatory standards. The role will support development projects by driving documentation excellence, process compliance, data integrity and timely release of development materials while fostering a strong quality culture within the R&D function.
Development Quality Assurance
- Provide Quality Assurance oversight for all R&D and development activities
- Review and approve synthesis procedures, analytical procedures, technical packages, specifications and Methods of Analysis (MoA)
- Review executed laboratory records, analytical protocols and development batch documentation to ensure completeness, accuracy and compliance
- Ensure compliance with applicable quality systems, ISO standards and internal procedures
Documentation & Quality Systems
- Manage issuance, revision, retrieval and archival of controlled QA documents including SOPs, BMRs, BPRs, specifications, analytical methods and related quality records
- Support document control, change control, deviations, investigations and CAPA implementation related to Development QA
- Ensure compliance with ALCOA+ principles and Data Integrity requirements
Material Release & Laboratory Compliance
- Review and release development-stage raw materials, intermediates and finished products as applicable
- Ensure accurate preparation of Certificates of Analysis (CoA), product labelling and documentation for customer dispatches
- Maintain control samples and ensure storage conditions are monitored and documented
- Monitor laboratory compliance, calibration status of analytical instruments and overall housekeeping within the R&D facility
SAP & Cross-functional Support
- Execute Quality-related SAP activities including material code creation, batch creation, batch release, quality inspection plans, reservation creation, MIGO transactions and related master data activities
- Collaborate with R&D, Production, QC, Supply Chain teams to support seamless technology development and transfer activities
Compliance, Safety & Continuous Improvement
- Conduct routine compliance walkthroughs and internal audits within the R&D facility
- Promote EHS compliance, safe laboratory practices and good housekeeping
- Identify opportunities for process improvement, documentation efficiency and quality system enhancement
Qualifications
- M.Sc. in Chemistry / Organic Chemistry / Analytical Chemistry or equivalent
Experience
- 8 – 10 years of experience in Quality Assurance within a pharmaceutical, specialty chemicals or CDMO environment, with exposure to Development QA or R&D Quality
- Good understanding of ISO 9001, documentation practices and Data Integrity requirements
- Experience with SAP (QM/MM modules) and document management systems will be preferred
