Asst. Manager QA and Regulatory

Role Overview: You should have a minimum of 6-8 years of experience in Quality assurance and regulatory, preferably in the field of pharmaceuticals, antibodies, proteins, IVD/medical devices, or injectables. As a Graduate or Post Graduate in Pharmacy, Biochemistry, Biotechnology, or Chemistry, you will be responsible for ensuring the quality control systems are implemented effectively and participating in various quality assurance activities. Your innovative thinking and leadership skills will be crucial in solving problems related to the Quality Management System. Key Responsibilities: - Monitor and ensure the implementation of Quality Control Systems - Provide training as and when required - Conduct internal audits regularly - Coordinate Batch failure and OOS Investigations, and implement appropriate Corrective and Preventive actions (CAPA) - Qualification and Validations (Revalidation) of facility, equipment, and processes - Participate in Vendor development and audits for raw materials and packing materials - Support the Quality Head in implementing the Quality Management System effectively - Assist in maintaining the effectiveness of the established strategic vision for Quality Assurance Qualifications Required: - Graduate and/or Post Graduate in Pharmacy, Biochemistry, Biotechnology, or Chemistry - Knowledge of techniques involving quality assurance of pharmaceuticals antibodies/ Proteins - On-job knowledge of in vitro MDD / IVD documentation - Minimum 6-8 years of experience in Quality assurance and regulatory, preferably in IVD/medical devices or injectables in an Executive / Managerial position - Innovative thinking for problem-solving and leadership skills - Good written and spoken English - Computer proficiency in MS Excel, PPT, Word Please note that the company's additional details were not provided in the job description.,