Deputy General Manager/ Associate General Manager - Corporate Quality

As an experienced candidate with 18 to 20 years of experience, your role will involve the following responsibilities: - Review and approve change controls initiated by plants and forward them to CQA for approval. - Review and approve vendor qualification documents to ensure effective implementation of the vendor approval system. - Conduct and oversee internal audits at all plants and corporate departments according to the annual planner. - Prepare and implement audit reports and compliance reports in alignment with the CAPA plan. - Monitor and ensure that all plants adhere to cGMP, cGLP requirements, and good documentation practices. - Review and approve CQA guidelines, updating them in line with regulatory requirements. - Approve SOPs of Corporate departments. - Review and approve various documents such as change controls, deviations, protocols, reports, qualification documents, stability protocols, and MPR of corporate departments. - Assist plants in reviewing regulatory compliance reports and customer quality agreements. - Ensure detailed investigations are conducted for out-of-specifications, market complaints, product recall, stability failures, and implement appropriate CAPA as per procedures. - Ensure all team members are trained and updated in accordance with regulatory requirements. Desired Skills: - Adequate experience in facing regulatory inspections from authorities like USFDA, MHRA, EMA, TGA, etc. - Experience in auditing finished dose formulation units, API, and Intermediate/KSM vendors. - Preferably, experience working in both Formulation unit and API unit. - Strong functional knowledge and practical application. - Proactive approach to handling internal and external queries. - Ability to manage multiple stakeholders effectively. - Uphold high standards of business ethics. - Excellent communication and decision-making skills.,