Job Description

Position Overview
The Quality Assurance Manager will be responsible for managing day-to-day QA activities related to production support, documentation review, deviation investigation, and ensuring compliance with cGMP standards. This role serves as a critical link between production, quality control, and regulatory compliance teams to maintain the highest level of quality for all products manufactured.
Key Responsibilities
Manage batch record reviews, ensuring accuracy and compliance prior to final product release.
Oversee the handling and closure of non-conformances, deviations, and CAPAs within defined timelines.
Supervise in-process quality checks on the production floor to ensure adherence to SOPs and cGMP.
Conduct quality training sessions for production and QA personnel.
Participate in internal audits and support implementation of corrective and preventive actions.
Assist in maintaining and updating standard operating procedures (SOPs), work instructions, and controlled documents.
Monitor and report on quality KPIs, such as deviation trends, document compliance, and audit readiness.
Work with cross-functional teams (Production, QC, Engineering) to identify and mitigate compliance risks during manufacturing.
Support validation and qualification activities related to facilities, utilities, equipment, and processes.
Ensure proper documentation and traceability throughout the product lifecycle.
Qualifications
Bachelor’s or master’s degree in pharmacy, Chemistry, Life Sciences, or a related field.
Minimum of 7–10 years of QA experience in a pharmaceutical manufacturing environment (sterile injectables preferred).
Sound knowledge of FDA regulations, cGMP, ICH Q-series guidelines, and industry best practices.
Experience in managing document control and batch record reviews.
Strong attention to detail and analytical thinking.
Effective team leadership, communication, and interpersonal skills.

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