Job Title: Associate Manager – Quality Assurance
About Our Company:
We are a leading pharmaceutical company dedicated to improving global health through the development and manufacturing of high-quality medicines. Our commitment to excellence, innovation, and patient safety is at the core of everything we do. Join our dynamic team and contribute to a mission that makes a real difference in the lives of millions.
The Opportunity:
We are seeking a highly motivated and experienced Associate Manager of Quality Assurance to play a critical role in upholding our rigorous quality standards. In this on-premise position, you will be instrumental in ensuring regulatory compliance and supporting the seamless technology transfer and production of sterile injectable products. This role requires a proactive approach and a deep understanding of pharmaceutical quality systems in a fast-paced environment.
What You Will Do:
- Review and approve change controls, ensuring strict compliance with Standard Operating Procedures (SOPs) for technology transfer and adherence to configuration management policies.
- Oversee and approve all validation protocols and reports, including Process, Cleaning, Filter, and Project Validations, PRQs, and PRs, to maintain a robust validation lifecycle that meets regulatory expectations.
- Provide essential quality support and review for production-related documents, scale-up, pilot bio batches, and exhibit batches.
- Lead Quality Assurance activities for New Product Introduction (NPI) projects, striving for zero-defect technology transfer for new sterile injectable products.
- Review critical documentation such as Optimization Reports, Technology Transfer Reports, Analytical Data Sheets, and Stability Data.
- Evaluate Analytical Method Transfer and Method Validation Reports, identifying and addressing key changes across various transfer sites.
- Champion continuous improvement initiatives for quality system tools, including templates for presentations, timelines, and trackers.
- Assess commercial drug batches to confirm their adherence to established specifications and quality attributes.
- Independently evaluate Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
- Investigate and meticulously document Quality Assurance deviations, escalating issues to leadership as required.
- Ensure comprehensive regulatory compliance with current Good Manufacturing Practices (GxP) and provide meticulous Quality Review and oversight of site documentation to meet global regulatory and internal quality standards.
What You Bring:
- Education: B. Pharm, M. Pharm, or M. Sc degree.
- Experience: 6-7 years of progressive experience in Quality Assurance within sterile injectable manufacturing, with a focus on technology transfers and validations.
- A solid understanding of current Good Manufacturing Practices (cGMP) and relevant GxP regulations and industry standards.
- Demonstrated strong critical thinking and effective problem-solving abilities.
- Excellent collaboration skills, with the ability to work effectively within diverse teams and across interdepartmental functions.
- Proficiency in Microsoft Excel and Word.
Work Location: On-Premise
We are an equal opportunity employer and are committed to creating a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
