Quality Assurance Officer

Time Pharmaceuticals Limited; Etmadpur; In loco; INR 300.000 - 500.000; Tempo pieno

Descrizione del lavoro

Time Pharmaceuticals Limited seeks a Quality Assurance Officer to ensure daily product quality and regulatory compliance. The role involves handling BMRs, formats, log sheets, line clearances, and data crosschecks to maintain GMP standards.

You will actively participate in QA activities including calibrations, validations, DOIs like Water System Qualification, Vendor Validation, and Process Validation, and support deviation/cAPA processes, incidents, OOS, and customer complaints.

Competenze

• Asst. pharmacist with Bachelor of Pharmacy is required.
• Fresher are highly encouraged to apply.
• Basic knowledge of MS Office.
• Excellent oral and written communication.

Mansioni

• Perform routine QA documentation for BMR, formats, log sheets and line clearance.
• Actively participate in QA activities such as calibrations, validations, vendor validation and process validation.
• Assist in documenting deviation, change control, CAPA, incidents, OOS, customer complaints and nonconformities.
• Prepare weekly QA status reports and monthly reports; contribute to KPI evaluations and Annual Product Review.
• Conduct periodic rounds in Warehouse, Production, QC Lab and Maintenance to ensure GMP/GLPs/GHPs compliance.

Conoscenze

Communication skills

Formazione

Bachelor of Pharmacy (B.Pharm)

Strumenti

MS Office

Descrizione del lavoro

Job Purpose

Executes daily maintenance of product quality by strictly following established regulatory guidelines and ensuring the best efficiency of production processes.

Roles Of Quality Assurance Officer

• To perform routine jobs related to issue of Batch Manufacturing record (BMR), Formats, Log sheets, line clearance, crosscheck of BMR, Analytical worksheets and Finished products to ensure quality in product.
• To actively participate in periodic QA activities such as calibrations, Water System Qualification, Air Handling Unit Validation, Vendor Validation, Process Validation, Balance Calibration, Environment Monitoring, Boiler Test and others (e.g. Hygrometer, Thermometer, Magnehelic Gauge, Pressure Gauge).
• To actively participate in the implementation and documentation of deviation, change control, CAPA, Incidents, OOS, Customer complaints and nonconformities.
• To prepare Weekly status report (QA), Monthly reports and to participate in evaluation of Key Performance Indicators (KPIs) of GMPs, Annual Product Review.
• To take periodic rounds in the Warehouse, Production, QC Lab, Research and Development Department, Maintenance and factory premises to verify that logs, BMRs and other data entries are concurrent with the process, operational data within the specifications and also GMPs/ GLPs/ GWPs and GHPs are followed

Required Competencies

• He/She should be a Asst. pharmacist with a minimum degree of Bachelor of Pharmacy (B.Pharm)
• Fresher are highly encouraged to apply.
• Basic knowledge of MS Office

Language Skills

• Excellent oral and written communication skill.