Officer - Quality Assurance

Role Overview: You will be responsible for implementing the overall Quality Management System (QMS) in the laboratory and preparing all necessary documents. Additionally, you will manage both internal and external audits, including regulatory audits. Expertise in handling audits from USFDA, Anvisa, TGA, UK-MHRA, State FDA, ISO, and NABL is crucial. Conducting training sessions for existing and newly recruited staff, as well as handling QA tools, agreements, and legal documents, are also part of your core responsibilities. Key Responsibilities: - Implementing the overall Quality Management System (QMS) in the laboratory - Preparing all necessary documents - Managing internal and external audits, including regulatory audits - Conducting training sessions for staff - Handling QA tools, agreements, and legal documents Qualifications Required: - M.Sc in Chemistry - 3 to 4 years of experience in a pharmaceutical or FDA regulated laboratory - Technical skills: GMP, GLP & GDP knowledge, documentation skills, process understanding, risk assessment Additional Details: You will also be expected to support the team in developing clients, assisting ADL candidates in method development, and handling stability documents. If you are interested, please share your updated resume at harish.patil@cotecna.co.in or contact 9821081836 for more information. Note: This is a full-time position with benefits including health insurance, leave encashment, life insurance, and provident fund. The work location is in person at Digha, Navi Mumbai. Role Overview: You will be responsible for implementing the overall Quality Management System (QMS) in the laboratory and preparing all necessary documents. Additionally, you will manage both internal and external audits, including regulatory audits. Expertise in handling audits from USFDA, Anvisa, TGA, UK-MHRA, State FDA, ISO, and NABL is crucial. Conducting training sessions for existing and newly recruited staff, as well as handling QA tools, agreements, and legal documents, are also part of your core responsibilities. Key Responsibilities: - Implementing the overall Quality Management System (QMS) in the laboratory - Preparing all necessary documents - Managing internal and external audits, including regulatory audits - Conducting training sessions for staff - Handling QA tools, agreements, and legal documents Qualifications Required: - M.Sc in Chemistry - 3 to 4 years of experience in a pharmaceutical or FDA regulated laboratory - Technical skills: GMP, GLP & GDP knowledge, documentation skills, process understanding, risk assessment Additional Details: You will also be expected to support the team in developing clients, assisting ADL candidates in method development, and handling stability documents. If you are interested, please share your updated resume at harish.patil@cotecna.co.in or contact 9821081836 for more information. Note: This is a full-time position with benefits including health insurance, leave encashment, life insurance, and provident fund. The work location is in person at Digha, Navi Mumbai.