Senior Executive

RESPONSIBILITIES

• Effective implementation of cGMP and Quality management system by incorporating changes as per Guidelines.
• Control of necessary documents like SOPs, BPRs, formats, issue and distribution, followed by implementation of Quality management system and retention of documents.
• Preparation and review of ISO documents as per ISO 9001:2015.
• Review of all the procedures Viz... BPRs, Formats, Records, Validation Protocols, and Reports prior to the approval.
• Responsible for the QMS activities.
• Review of validation documents.
• Perform Internal Quality Audits as per the schedules.
• Review of Annul product Quality review of various products.
• Handling of deviations, change controls, customer complaints, return goods and OOS as per procedures.
• Review of executed Batch production records.
• Monitoring of preventive maintenance schedule activities and calibration of equipments / instruments as per schedules.
• Review of validation reports, water trend reports, and utility periodical validation reports.
• Review of Equipment Qualifications protocols and reports (IQ,OQ & PQ)
• Authorized to release finished product to market dispatch as per SOP.
• Coordinate to other departments during investigations, corrective action and preventive actions.
• Follow up of proposed corrective and preventive actions and review for its effectiveness
• Review of IPQA observations and coordinating with team members to resolve the issues by implementing suitable corrective and preventive actions.
• Identifying the gaps in the procedures and practices and complying the procedures by proper evaluation.
• Ensuring good relations and communications with all team members and in a timely fashion for complies with the internal and external customers.
• Ensuring good discipline, proper communication of allotted works, reporting & responding politely to HOD / Designee for execution of works as per timelines.
• Any other job assigned by the reporting authority as on need basis & ensuring the completing the tasks as per allotted timelines.