Schedule and prepare protocols/reports and conduct process and cleaning validation.
Provide ongoing training, motivation, coaching, support, and correction to employees to ensure that quality standards are met.
Responsible for investigation of deviations, complaints, and recalls in coordination with RA.
Issue controlled documents, e.g. specifications, BMRS, BPRs, preventive maintenance,... facility layouts, SOPs, protocols, etc.
Collect and compile statistical quality data, keeping accurate record of the same (APQR)
Monitor cleaning of warehouses, temperature mapping, and recording.
Support the quality assurance team leaders to ensure the development of fit-for-purpose QA policies and procedures and monitor the implementation and effectiveness of the same.
Document and report quality issues to management and other departments.
Verify the received materials on receipt and ensure that it adheres to the accepted quality limits.
Carry out online inspections of documents for compliance to data integrity.
Be responsible for the retention, issuance and destruction of all records.
To follow up on the approved reprocessing and reworks
To follow up on the Approved Change controls, CAPA, Risk
To ensure that the required initial and continuing training of quality control personnel is carried out and adapted according to the need.
Online documentation; log books, reports and BMRs. more

To implement SOPs for production and report if any deviations are observed to the Production Manager.
To check the in-process control parameters of production.
To ensure the implementation of the environment norms of various production areas as defined and get the deviation corrected by the utility department.
To ensure implementation of a preventive maintenance schedule for the equipment... and machines in the department.
To check the yield at various operational points to improve the result through correct implementation of SOPs.
To implement CGMP norms in the production area and also during manufacturing and on a continuous basis.
Oversee all production operations, cleanliness of the area, all documents, and staff.
To oversee cleaning operations in the department by cleaning contract team & report to the Head of Production.
To plan for manpower requirements for casual workers in the department apart from the packing section. more

To ensure that all breakdown and preventive maintenance of plant machinery is done efficiently to meet the required standards and maintain equipment quality.

Troubleshooting mechanical malfunctions and breakdowns, as well as performing repairs.
Optimizing mechanical efficiency by adjusting machinery and equipment settings.
Resolve motor, pump, conveyor, pneumatic, hydraulic, and transmission... problems.
Ensure working with team and independently.
Comply with company safety guidelines and procedures.
Repair and perform preventive maintenance as per established standards.
Handle personal tools as per tool list.
Time accounting to complete work order.
Works all shifts flexibly when job demand.
To ensure proper understanding, reading, and interpretation of the mechanical drawings.
To always maintain the logbooks for servicing equipment.
Maintain and repair of all plant machines and utility.
To follow P.M.S plan for all machines
To maintain all plant machines so as to reduce frequent breakdowns and the cost of repair.
To check on oil and lubrication system for all machines and utilities.
To check and control all leakages for steam, water and compressed air in the plant. more

Key Duties and Responsibilities:

Schedule, prepare protocol/reports and conduct process and cleaning validation.
Provide ongoing training, motivation, coaching, support and correction to employees to ensure that quality standards are met.
Responsible for investigation of deviations, complaints and recalls in coordination with RA.
Issue controlled documents e.g. specifications, BMRS, BPRs,... preventive maintenance, facility layouts, SOPs, protocol etc.
Collect and compile statistical quality data, keeping accurate record of the same (APQR)
Monitor cleaning of warehouses, temperature mapping and recording.
Support the quality assurance team leaders to ensure the development of fit for purpose QA policies and procedures and monitor implementation and effectiveness of the same.
Document and report quality issues to management and other departments.
Verify the received materials on receipt and ensure that it adheres to the accepted quality limits.
Carry out online inspections of documents for compliance to data integrity.
Be responsible for Retention, issuance and destruction of all records.
To follow up on the approved reprocessing and reworks.
To follow up on the Approved Change controls, CAPA, Risk
To ensure that the required initial and continuing training of quality control personnel is carried out and adapted according to the need.
Issuing controlled documents.
Deviation reporting on non-conforming activities.
Line clearance for all production activities.
Approval/Rejection on receipt of Starting materials. more