Officer/Sr. Officer/Executive/Sr. Executive (Quality Assurance)

As an Officer/Sr. Officer/Executive/Sr. Executive with 2-8 years of experience in a Parental plant, your role will involve the following key responsibilities: - Prepare, review, and implement Standard Operating Procedures of Quality Assurance. - Ensure that day-to-day QA controls are in place and empower QA for the entire plant. - Establish, implement, and maintain process needs for the Quality Management System. - Adopt a document control procedure to approve, review, and update all changes to documents within the scope of the Quality Management System. - Issue Quality Management System related formats and maintain the log accordingly. - Take necessary follow-ups related to deviations, change control, incidents, material and product destructions, Internal Audit, re-packing activity, and corrective & preventive actions with respective departments. - Prepare risk assessment documents. - Review the performance of the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. - Maintain documents as per current Good Manufacturing Practices. - Intervene and call meetings to resolve QMS and GMP related queries. - Provide documents for regulatory affairs and handle regulatory queries. - Co-ordinate with internal department personnel as well as external parties. - Prepare for audit preparation, execution, and compliance. - Handle notifications to management related to documents. - Investigate and review non-conforming events including customer complaints and internal non-conforming events, decide on CAPA, and follow through for implementation. - Prepare, review, and implement the Master list of Standard Operating Procedures. - Review qualification and validation documents. - Review and implement Annual Training Plan of GMP/Technical/SOP training, coordinate with the concern department for the execution of ATP, maintain training records, and train departmental staff on their respective jobs. - Verify and implement the Batch Numbering system. - Allocate Equipment identification numbers and review and follow up for updating the equipment/instrument list. - Update/review approved vendor lists, vendor qualification planning, and documents. You will play a crucial role in ensuring the quality and compliance standards are met within the organization.,