Quality Associate III

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.
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Qualification

Strong knowledge of:

• Analytical techniques (HPLC, GC, spectroscopy, dissolution),
• Method validation and Method transfer,
• Analytical Equipment Qualification,
• Stability studies and impurity profiling,
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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