Job Title: Officer / Senior Officer – Lab Quality Assurance (QA)
Company: Aristo Pharmaceuticals
Location: Sikkim, India
Department: Lab QA
About Aristo Pharmaceuticals:
Aristo Pharmaceuticals is a rapidly growing and reputable pharmaceutical company dedicated to advancing healthcare through high-quality and innovative medicinal products. With a strong commitment to excellence and patient well-being, we foster an environment of scientific rigor, continuous improvement, and professional growth. We are proud of our state-of-the-art facilities and our team of dedicated professionals who work tirelessly to maintain the highest standards of quality and compliance in all our operations. Join us in our mission to make a significant impact on global health.
About the Opportunity:
Aristo Pharmaceuticals is seeking a diligent and experienced Lab Quality Assurance professional to join our team in Sikkim. This critical role ensures the integrity and compliance of our laboratory activities, upholding the highest industry standards. As an Officer or Senior Officer in Lab QA, you will play a pivotal role in reviewing analytical data, managing quality processes, and supporting regulatory audits, contributing directly to the quality assurance of our pharmaceutical products.
Key Responsibilities:
- Review and verify all Quality Control (QC) analytical data, including calculations, chromatograms, spectra, and analytical records essential for batch release.
- Conduct thorough reviews and evaluations of Out-of-Specification (OOS), Out-of-Trend (OOT) results, deviations, incidents, investigations, and Corrective and Preventive Actions (CAPA) related to laboratory operations.
- Manage the stability program, encompassing the review of stability protocols, reports, data analysis, and trend identification.
- Oversee the review of analytical method validation/verification, method transfer protocols, instrument qualification/calibration documentation, and other relevant laboratory documentation.
- Ensure strict compliance with Good Manufacturing Practices (GMP), ALCOA+ principles, and data integrity requirements within all QC laboratory activities.
- Prepare and review Standard Operating Procedures (SOPs), protocols, reports, and other Lab QA documents, providing crucial support during regulatory and customer audits.
Qualifications:
- Education: B. Pharm, M. Pharm, or M.Sc. in a relevant scientific discipline.
- Experience: Previous experience in a Lab QA role within the pharmaceutical industry is highly preferred.
- Skills: Strong understanding of GMP, GLP, ALCOA+, data integrity principles, and regulatory requirements. Excellent analytical, communication, and documentation skills.
Why Join Aristo Pharmaceuticals?
At Aristo Pharmaceuticals, we believe our people are our greatest asset. We offer a challenging yet rewarding work environment where innovation is encouraged, and professional development is prioritized. You will be part of a dynamic team, working on critical projects that ensure product quality and patient safety. We offer competitive compensation and opportunities for career advancement within a leading pharmaceutical organization.
Application Process:
Interested and qualified candidates are encouraged to submit their updated resume for consideration. Please ensure your resume highlights your relevant experience and qualifications for this role.
