Senior Executive

Metrochem API Private Limited; Hyderabad; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Metrochem API Private Limited is looking for an experienced professional in Hyderabad to implement quality management systems and conduct internal quality audits. The role includes preparing and reviewing ISO 9001:2015 documents, handling customer complaints, and ensuring compliance with quality guidelines. Ideal candidates should have a strong background in cGMP, quality documentation, and effective communication skills. This position offers a chance to contribute significantly to the quality assurance processes within the company.

Qualifications

• Experience in implementing cGMP and quality management systems.
• Knowledge of ISO 9001:2015 requirements.
• Ability to perform internal quality audits.

Responsibilities

• Implement and manage quality management systems as per guidelines.
• Conduct internal audits and review validation documents.
• Handle deviations and coordinate corrective actions.

Skills

cGMP implementation

ISO 9001:2015 documentation

Internal Quality Audits

Deviation handling

Communication

Education

Degree in relevant field

Job description

• 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.