Ashish Tambe

About Ashish Tambe

With over 30 years of experience in the regulated pharmaceuticals industry and FMCG company. A skilled and responsive Senior Quality & Audit Director, able to manage interfaces with senior stakeholders, including heads of departments and cluster leads through multi-faceted audit processes. My key expertise include• Expertise in managing strategic & operational performance of Quality Department involving development & implementation of standardized quality systems in API, R&D sites and manufacturing of various dosage forms such as Solid & Liquid Orals, Topical, Nutraceuticals, Food, Sterile, and Aerosols as well as commercial quality.• Extensive experience in ensuring quality & compliance, managing risk, internal & external audit, facilitating technology transfer in Pharmaceutical & Consumer Durables industries.• Ensuring an effective governance structure to ensure oversight of quality activities is maintained and providing expertise for GMP & GDP activities for internal sites, suppliers and CMOs. Successfully delivered GMP/GDP quality strategies.• Proficient in leading global projects through excellent communication and organization skills with ability to make decisions, conducting audits, implementing quality management systems, with a strong focus on capability building, data integrity, and quality compliance.• Bridging of the technical requirements within Quality and balancing this with industry standards to achieve business goals.• Excellent track record of assuring that all products produced represent the maximum quality and reliability attainable by establishing effective quality compliance inspections, tests and corrective procedures.• Sound understanding of standards & systems of USFDA, MHRA, EUGMP and strong exposure of participating in external audits of respective regulatory authorities and performing review of ANDA filings & deficiency response to FDA.• Often autonomous and able to lead multi departmental and global projects.• Visited various countries such as UK, USA, Japan, Germany, Singapore, UAE, Saudi Arabia, Egypt, Vietnam, Indonesia, and Sri Lanka. Handling a team of technical people to support trouble shooting at contract manufacturering locations, technology transfers as well as recommending and implementing associated change and improvements. A subject matter expert for Data Integrity. I am looking for a senior management leadership role in Quality Organisation involving QMS Design and Implementation, Audit and Compliance, Risk Mangement and Capability Building.

Experience

1. Head of Quality Assurance

   Athena Pharmaceutiques S.A.S.

   Dec 2025 — Present · Thane, IN

Education

• University of Mumbai

  Masters in Chemistry, Analytical Chemistry

• Saraswati Secondary School, Thane

  SSC, Science, Maths

• University of Mumbai

  Master of Science (M.Sc.), Inorganic Chemistry

  1992 — 1994

Skills

• Customer Service
• Change Management
• Corrective and Preventive Action (Capa)
• Technical Risk Assesment
• Root Cause Analysis
• Quality Assurance
• Microsoft Excel
• Managing External Sites
• Management
• Pharmaceutical Industry
• Deviation Management
• Project Management
• Microsoft Office
• Sales
• Regulatory Compliance
• Leadership
• Quality Control
• Strategic Planning
• Product and Technology Transfer
• Equipment Qualification
• Quality Auditing