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.