Essential Duties And Responsibilities

- Provide QA oversight for analytical laboratories (internal and external).
- Review and Approve Analytical method validation protocols and reports, Stability study protocols and reports, Specifications and test methods and Certificates of analysis (CoA).
- Review and Approve extractables and leachables study plans, protocols, and reports.
- Review and approve investigations for; OOS (Out of Specification), OOT (Out of Trend), Deviations and Incidents.
- Ensure all analytical work complies with GMP, GLP, and Data Integrity principles.
- Monitor lab compliance and drive quality improvements.
- Ensure analytical data meets requirements for global registrations (e.g., US FDA, EMA, ROW).
- Participate in health authority inspections and audits.
- Ensure integrity and traceability of analytical data (ALCOA principles).
- Oversee electronic systems qualifications & usage such as LIMS, ELN, and data management tools.
- Identify and mitigate data integrity risks.
- Lead investigations related to data inconsistencies.
- Perform CAPA reviews and provide input to management reviews.
- Support CRO OOL, OOS and provide insight to the ongoing Investigations and SCAR's.
- Responsible for the compliance and approval of PDLM records, per Vantive procedures throughout the product lifecycle.




- Collaborate with regulatory affairs as needed to guide teams in meeting quality/regulatory requirements based on the regulatory plan/strategy or assessment.
- Collaborate with teams to provide strategy and guidance for meeting Vantive Requirements and External Quality Standards as appropriate.
- Qualification

Robust knowledge of

- Analytical techniques (HPLC, GC, spectroscopy, dissolution),
- Method validation and Method transfer,
- Analytical Equipment Qualification,
- Stability studies and impurity profiling,
- Deep understanding of GMP / GLP requirements, ICH guidelines (Q2, Q6, Q7, Q8, etc.) and, Global pharmacopeias (USP, EP, BP) not limited to USP ,

Good interpersonal/communication/influencing/negotiation skills.

Good analytical and problem solving skills.

Working knowledge of FDA Regulations.

Demonstrated ability to lead others within small project or investigational environments.

Education And Experience

10 years in Analytical chemistry and/or QA roles.

Minimum 4–6 years in QA oversight of analytical functions and exposure to E&L; studies or related fields (container closure, packaging, or impurity analysis).

Strong experience in regulatory submissions and product registrations

📌 Quality Associate III (Bengaluru)
🏢 VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE
📍 Bengaluru