Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Position: Head - Quality Assurance (Formulation R&D) Markets: USA + Other Regulated Products: Formulations Reporting to: CEO Role & responsibilities Responsible for overseeing all aspects of quality management and compliance of Contract Research Organization facilities mainly for regulated markets i:e USA for different types of formulations. This individual ensures that Product Development and research activities adhere to regulatory guidelines, industry standards, and the organization's internal policies. To ensures the organization's research and development activities meet regulatory, ethical, and quality standards. Responsible for establishing, implementing, and maintaining the organization's quality management system (QMS), ensuring it aligns with Good Laboratory Practice (GLP) guidelines and relevant regulatory requirements Lead investigations into quality issues and deviations, ensuring proper CAPA (Corrective and Preventive Actions). Identify, assess, and mitigate risks related to research quality. Serve as the primary liaison for regulatory authorities during inspections. Review and approve QA-related SOPs, policies, and procedures. Reviewing data, reports, and other documentation to ensure accuracy, completeness, and compliance with quality standards. Oversees audit preparation and execution, addressing any findings and implementing corrective actions. Conducting internal audits to assess compliance with SOPs, regulatory requirements, and GLP guidelines, as well as audits and inspections from regulatory bodies. Managing & developing the QA team as well as ensuring that they possess the necessary skills and knowledge to carry out their duties effectively. Responsible for developing and implementing training programs for staff on quality management procedures and regulatory requirements. To critically evaluate and troubleshoot complex problems, making informed decisions that ensure the integrity of the research and compliance with regulations. Preferred candidate profile M.Sc / M.Pharm with 12 to 20 years of experience in Research Quality Assurance / Developmental Quality Assurance in Formulations Pharma / Biotech CRO or R&D Centre. 1220+ years in quality assurance, with at least 5 years in a leadership role. Strong background in GLP environments within a CRO or pharmaceutical R&D setup. Experience in a Quality Assurance, particularly in a Contract Research Organisation / CRO setting, is highly desirable. A deep understanding of GLP & USFDA regulations, and other relevant guidelines is essential. The ability to analyse complex data, identify potential issues, and develop solutions is necessary. Strong auditing and inspection readiness experience. The ability to lead and motivate a team, delegate tasks, and manage resources effectively is crucial. Effective communication, both written and verbal, is required for interacting with internal teams, external stakeholders, and regulatory agencies. Problem-solving and critical thinking. Detail orientation with a strategic mind-set. Recruiter's Contact Details: Dharmesh Sikligar BEST-FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09558802906 Website: www.bestfitrecruitment.co.in
