Quality Assurance Manager

Company Description SRUZAM Labs, based in Ahmedabad, is a growing pharmaceutical company offering a broad range of quality pharmaceutical products. The organization focuses on building sustainable business through efficient manufacturing and reliable supply of medicines to its customers and partners. As a WHO-GMP certified manufacturing unit, SRUZAM Labs upholds strict quality and safety standards. The company is progressing toward EU-GMP and PIC/S approvals, positioning itself to enter and compete in regulated international markets. This environment offers professionals opportunities to contribute to global-quality operations and long-term organizational growth.
Role Description The Quality Assurance Manager is a full-time, on-site role based at the SRUZAM Labs manufacturing facility in Ahmedabad. This position is responsible for overseeing day-to-day quality assurance activities, including implementation and monitoring of QA systems, documentation control, and compliance with WHO-GMP and other regulatory requirements. The role includes leading internal audits, managing deviations, change controls, and CAPA, and ensuring that manufacturing and packaging operations adhere to approved procedures. The Quality Assurance Manager will collaborate closely with production, quality control, and regulatory teams to maintain product quality, support inspections, and prepare for EU-GMP and PIC/S approvals. The position also involves training and mentoring QA staff, driving continuous improvement initiatives, and supporting risk management across the site.
Qualifications
Strong knowledge of pharmaceutical quality systems, including GMP, WHO-GMP requirements, and familiarity with EU-GMP and PIC/S guidelines.
Experience in QA processes such as documentation control, batch record review, deviation handling, change control, CAPA, and internal audits.
Ability to lead cross-functional teams, coordinate with production and QC, and manage regulatory and customer audits effectively.
Proficiency in preparing SOPs, validation documentation, and quality reports, with attention to detail and accuracy.
Excellent analytical, problem-solving, and decision-making skills, with a focus on continuous improvement and risk-based thinking.
Strong written and verbal communication skills for clear reporting, training, and stakeholder coordination.
Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related field; prior experience in pharmaceutical manufacturing QA is highly preferred.
Capability to work on-site in Ahmedabad, manage multiple priorities, and uphold high ethical and professional standards.

Work arrangement
No