Validation Specialist
2 weeks ago
Sun Pharma is seeking a highly skilled Validation Specialist to join our team. As a Validation Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical equipment and systems.
Responsibilities:
• Prepare and execute URS, IQ/OQ/PQ protocols and write summary reports for production and packaging equipment, utilities equipment like HVAC, Air compressor, Boiler, Purified water system, area qualification, and temperature mapping study of warehouse and storage area.
• Ensure that assigned validation activities are performed timely and in line with the current requirements and cGMP.
• To coordinate commissioning activities for engineering projects of new area and equipment
• To review and execute PPV (Periodical Performance Verification of equipment
• To develop calibration plan for new equipment
• Prepare and train for the Set up / Operational / Cleaning / Maintenance SOPs
• Identify, investigate and troubleshoot deviations for multiple concurrent projects
• Preparation of Personnel flow, Incoming and Finished material flow, as well as Waste flow in the facility
• To assist in preparation of internal audit, FDA, DEA and other agency audit responses.
• Prepare, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
• To write investigation and finished on timely manner.
• To create and closed all change controls, CAPA and investigation on timely manner.
• To create sops for facilities and utilities.
Requirements:
• Bachelor's Degree in Engineering or Science related field.
• Technical and analytical ability to analyze engineered systems and equipment operation as well as quality and compliance systems that supports production operations as well as research and development.
• Good understanding of cGMPs and good documentation practices in order to prepare system life cycle technical documents such as URS, FRS,VMP, protocol generation and execution to support FAT, SAT, commissioning, qualification (IQ, OQ), SOPs, Validation (PQ, DS, CV, PV), FMEA and Validation Master Plan.
• Technical knowledge to write, prepare and execute the Change Controls, Investigations, SOPs, protocols, final summary reports and validation documents.
• Demonstrated excellent communication: verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• A team building champion driving innovative cross functional synergies.
• Excellent project management and problem solving skill
Languages:
The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR
Sun Pharma offers a competitive compensation and benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, (k) savings plan, flexible spending accounts, and employee assistance programs. Employees also receive various paid time off benefits, including vacation time and sick time.
Please note that the compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
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