Sr. Quality Assurance Officer

Time Pharmaceuticals Limited; Etmadpur; Presencial; INR 500.000 - 800.000; Jornada completa

Descripción de la vacante

Time Pharmaceuticals Limited in India seeks a Sr. Quality Assurance Officer to oversee strategic maintenance of product quality and drive the best efficiency of quality processes while ensuring strict adherence to advanced regulatory guidelines.

The role includes trending of quality data, preparation of product quality reviews, and active participation in equipment qualification, validations, deviation control, CAPA, change control, and documentation across GMP-compliant products.

Formación

• Pharmacist with a minimum of B. Pharmacy/M. Pharmacy degree with at least 2-3 years’ experience.
• Knowledge and skills related to manufacturing processes, packaging science and GMP related to tablets, capsules, powder for reconstitution, external preparations, sterile preparation, oral liquids,
• Knowledge of MS Office / ERP software
• Pharma Solution software knowledge will give additional advantage.

Responsabilidades

• Oversee trending of quality related data and prepare product quality reviews.
• Perform equipment qualification (DQ, IQ, OQ, PQ) and maintain proper documentation.
• Participate in periodic QA activities such as calibrations, Water System Qualification, Air Handling Unit Validation, Vendor Validation, Process Validation, Balance Calibration, Environment Monitoring, Pest Control, Boiler Test.
• Assist in deviation, change control, CAPA, Incidents, OOS, Customer complaints and nonconformities documentation.
• Prepare MFRs, BMRs, Validations and Qualifications documents along with forms, templates and protocol; support Head of Quality Assurance.

Conocimientos

Quality data analysis

GMP knowledge

Documentation

Communication skills

Educación

B. Pharmacy / M. Pharmacy

Herramientas

MS Office

ERP software

Pharma Solution software

Descripción del empleo

Job Purpose

Oversees the strategic maintenance of product quality and drives the best efficiency of quality processes while ensuring strict adherence to advanced regulatory guidelines.

Roles Of Sr. Quality Assurance Officer

• To perform trending of quality related data and prepare product quality reviews.
• To perform equipment qualification (DQ, IQ, OQ, PQ) and maintain proper documentation.
• 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, Pest Control, 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 initiate preparations of documents such as MFRs, BMRs, Validations and Qualifications along with forms, templates and protocol and assist Head of Quality Assurance for their approvals.

Required Competencies

• He/She should be a pharmacist with a minimum of B. Pharmacy/M. Pharmacy degree with at least 2-3 years’ experience
• Knowledge and skills related to manufacturing processes, packaging science and GMP related to tablets, capsules, powder for reconstitution, external preparations, sterile preparation, oral liquids,
• Knowledge of MS Office / ERP software
• Pharma Solution software knowledge will give additional advantage.

Language Skills

• Excellent oral and written communication skill.