Assistant Manager QA

Job description

Actylis is a global solutions provider with over 75 years of experience, specializing in streamlining the management of critical ingredients and raw materials for our business partners. We offer both sourcing and manufacturing solutions tailored to meet diverse and evolving needs, ensuring a reliable, agile, and secure supply network. Our commitment to customization allows us to create flexible solutions, whether it’s a unique specification, custom packaging, or tailored logistics strategies. With deep expertise in quality and regulatory compliance, sourcing and logistics management, analytical services, and R&D support, we reduce complexities and mitigate risks, empowering our partners to focus on growing their business. In furtherance of that goal, Actylis is seeking new members of the team. This expansion, coupled with a comprehensive benefits package, and opportunities for challenge and growth, make Actylis the ideal place to work and thrive. We hope you’ll consider joining us! Position Summary This role defines the complete handling and monitoring of customer and regulatory audit lifecycle management with compliance followed with management of all validation process. The assigned personnel will also monitor and ensure audit readiness customer compliance and regulatory compliance. Will ensure completing the internal audits and supplier qualification. This role is having extended responsibility in product release, registration and new product development and launches related to Quality responsibility. Responsibilities will include: Primary responsible for managing and handling audits (Internal, Customer, Regulatory and Certification Body). Part of Quality improvement team and compliance to ensure system development. To manage and maintain all validation document and lifecycle at facility. Primarily responsible for assurance of quality matrix of the Ahmedabad site by assuring the quality management system like Management of Change controls, Management of Market complaint, Deviation Management, OOS management are been done per the define process work flow. Management of all CAPA for internal and external audit, including CAPA taken against any investigation with tracking, effectiveness verification and closure. To ensure Quality Matrix Monthly/Quarterly/Half yearly and Annual, preparation and compilation. To be responsible for batch release of finished products. Responsible for ISO, NABL, FSSC2200, EXCiPACT training and certification Responsible for Vendor audit for RM and PM and New PM vendor development process Required Experience & Knowledge Education: B.Pharma/M.Pharma, Msc. Chemistry, Btech or Mtech with biotechnology or chemistry. Experience: 10-15 Years of experience in Pharmaceutical, API or excipient regulated industries in different regulated markets like US, Europe & China. Supervisory Responsibilities Yes Actylis is an Equal Opportunity Employer. Actylis US does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.