GMP Coordinator

As a GMP Compliance Officer, your role will involve monitoring adherence to GMP standards across manufacturing, packaging, and storage processes. You will be responsible for performing routine audits and inspections to identify and resolve compliance gaps, ensuring that all equipment, materials, and processes comply with GMP and regulatory guidelines. Key Responsibilities: - Monitor adherence to GMP standards in manufacturing, packaging, and storage processes - Perform routine audits and inspections to identify and resolve compliance gaps - Ensure equipment, materials, and processes comply with GMP and regulatory guidelines You will also be required to review and approve batch records, SOPs, and related quality documents, maintaining accurate and up-to-date records of GMP activities and compliance measures. Additionally, you will ensure timely completion of deviations, CAPAs, and change controls. Furthermore, you will conduct GMP training sessions for employees at all levels, develop and update training materials, and foster a culture of quality and compliance within the organization. You will assist in preparation for regulatory inspections and customer audits, coordinating with QA and regulatory teams to implement audit findings and corrective actions. Moreover, you will identify opportunities to improve manufacturing processes while maintaining GMP compliance, collaborating with cross-functional teams to streamline operations and enhance product quality. You will oversee environmental monitoring and ensure compliance with cleanroom standards, as well as proper handling, storage, and labeling of raw materials, intermediates, and finished APIs. Qualifications Required: - Strong knowledge of GMP regulations and standards - Excellent attention to detail - Ability to work in a fast-paced environment - Strong problem-solving skills - Effective communication and teamwork abilities Qualification: M.sc/B.sc/ BE in Chemical. Job Experience: Minimum 5-10 years of experience in a GMP compliance role within the pharmaceutical industry, preferably in API/intermediates manufacturing. As a GMP Compliance Officer, your role will involve monitoring adherence to GMP standards across manufacturing, packaging, and storage processes. You will be responsible for performing routine audits and inspections to identify and resolve compliance gaps, ensuring that all equipment, materials, and processes comply with GMP and regulatory guidelines. Key Responsibilities: - Monitor adherence to GMP standards in manufacturing, packaging, and storage processes - Perform routine audits and inspections to identify and resolve compliance gaps - Ensure equipment, materials, and processes comply with GMP and regulatory guidelines You will also be required to review and approve batch records, SOPs, and related quality documents, maintaining accurate and up-to-date records of GMP activities and compliance measures. Additionally, you will ensure timely completion of deviations, CAPAs, and change controls. Furthermore, you will conduct GMP training sessions for employees at all levels, develop and update training materials, and foster a culture of quality and compliance within the organization. You will assist in preparation for regulatory inspections and customer audits, coordinating with QA and regulatory teams to implement audit findings and corrective actions. Moreover, you will identify opportunities to improve manufacturing processes while maintaining GMP compliance, collaborating with cross-functional teams to streamline operations and enhance product quality. You will oversee environmental monitoring and ensure compliance with cleanroom standards, as well as proper handling, storage, and labeling of raw materials, intermediates, and finished APIs. Qualifications Required: - Strong knowledge of GMP regulations and standards - Excellent attention to detail - Ability to work in a fast-paced environment - Strong problem-solving skills - Effective communication and teamwork abilities Qualification: M.sc/B.sc/ BE in Chemical. Job Experience: Minimum 5-10 years of experience in a GMP compliance role within the pharmaceutical industry, preferably in API/intermediates manufacturing.