Executive

Sun Pharma; Mumbai; Presencial; INR 1 500 000 - 2 100 000; Tempo integral

Resumo da oferta

Sun Pharma is seeking a Validation Supervisor - QE in Pithampur. The role involves leading qualification lifecycle activities for equipment and utilities across cleanrooms and aseptic areas, ensuring data integrity and adherence to cGMP.

You will review IQ/OQ/PQ protocols and collaborate with Production, QA, Engineering and external vendors. Qualifications include B.Pharma/M.Pharma/M.Sc with 6+ years in QA/QC validation, strong documentation discipline, and familiarity with Kay/e Ellab systems.

Qualificações

• Qualification lifecycle management experience (URS, risk assessments, DQ/IQ/OQ/PQ, PPQ).
• Strong knowledge of cGMP and regulatory expectations.
• Experience with QMS, CAPAs, deviations and change controls.

Responsabilidades

• Prepare, review and maintain qualification protocols and reports for equipment (vial washing machines, depyrogenation tunnels, isolators, sterilisers, inspection machines, lyophilizers, filling/sealing machines).
• Prepare, execute, review and compile qualification for utilities (WFI, PSG, compressed air, nitrogen, HVAC; BMS/EMS qualification).
• Conduct temperature mapping for storage areas, warehouses, incubators and controlled environments.

Conhecimentos

Qualification lifecycle

cGMP compliance

QMS experience

Documentation control

Cross-functional coordination

IQ/OQ/PQ熟悉

Formação académica

B.Pharma

M.Pharma

M.Sc.

Ferramentas

KAYE

Ellab

Descrição da oferta de emprego

Validation Supervisor - QE

Business Unit: Sun Global Operations

Job Grade: G12A

Location: Pithampur

At Sun Pharma, we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine

As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys.

1. Preparation, Review and maintain qualification lifecycle documents including User Requirement Specifications (URS), cGxP Assessments, Risk Assessments, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Periodic Performance Qualification (PPQ).
2. Departmental QMS activity.

Tasks:

1. H E / SHE is to involve in the following qualification activities either as an executor or as a reviewer:

• Preparation, Review of Qualification Protocol (IQ, OQ & PQ) and Qualification Report for the equipment like vial washing machines, depyrogenation tunnels, isolators, steam sterilizers, terminal sterilizers, Visual inspection machine, Lyophilizer, filling machines, sealing machines etc.
• Prepare, execute, review and compile qualification protocols and reports for utility systems including Water for Injection (WFI), Pure Steam Generation (PSG) systems, compressed air systems, nitrogen systems HVAC System etc. & Building Management System (BMS) / Environmental Monitoring System (EMS) qualification activities.
• Prepare protocols, perform execution, analyze data and compile reports for temperature mapping studies of storage areas, warehouses, incubators, refrigerators, freezers and controlled environmental chambers.
• Prepare, execute, review, and approve qualification and validation documentation for Process Control Systems (PCS) and GxP computerized systems, including risk assessments, IQ/OQ/PQ protocols, functional testing,
• Operate and maintain thermal mapping and validation equipment, including data loggers and software such as KAYE / Ellab and equivalent systems for qualification and validation studies.
• Develop smoke study protocols, execute airflow visualization studies, review recorded videos and prepare reports to demonstrate unidirectional airflow compliance in aseptic processing areas.
• Initiate, review, and support Quality Management System (QMS) activities including Change Controls, Deviations, CAPAs, Impact Assessments and related quality events through electronic quality management systems.
• Coordinate with cross-functional departments including Production, Quality Control (QC), Engineering, Quality Assurance (QA) and external vendors to ensure timely completion of qualification projects and activities.
• Ensure continuous adherence to cGMP requirements, data integrity principles, aseptic processing standards and sterile manufacturing regulations during all qualification and validation activities.
• Balance, Weight box and weight calibration report/ certificates and schedule.
• Equipment requalification schedule.
• Document issuance and Retrieval.

1. Preparation and revision of QE SOPs.
2. Handling of any other activities / tasks allotted by department head.

Education Qualification

B.Pharma /M.Pharma/M.Sc.

Experience

Tenure: 6+ Years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth.

Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).