Qualification Specialist

2 weeks ago


Trenton, United States Synkriom Full time

Job DescriptionJob Description

Commissioning/Qualification

Specialist/Validation 100% Onsite --Warren, NJ--Local candidates only Work Schedule: Mon - Fri, Business Hours''

DUTIES AND RESPONSIBILITIES 1) Commissioning and Qualification:

a. Administer change control activities and corrective and preventive actions. b. Review, approve, and execute test protocols, validation deliverables, and plans as needed. c. Author, review, and approve SOPs, work practices, and other procedural documents. d. Provide input and guidance for change strategy, risk assessment, testing and compliance gaps. e. Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.

2) Promotes and provides excellent customer service and support:

a. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests. b. Provides technical support and guidance on equipment commissioning and qualification. Interfaces with customers to ensure all expectations are met. c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.

3) Communication and Management of Timelines:

a. Ensures timely completion of equipment commissioning and qualification projects, individually and/or with support of contracted personnel. b. Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment to affected stakeholders. c. Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.

4) Regulatory Responsibilities:

a. Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other BMS standards and regulations. b. Acts as equipment commissioning and qualification SME in internal and regulatory audits.

EDUCATION AND EXPERIENCE: • CRITICAL FOR THE JOB - BS in Engineering required. Must be able to read and understand construction and mechanical drawings and P&IDs. • Minimum of 7 years of experience in FDA-regulated industry. • Minimum of 3 years of experience executing projects of low to medium complexity. • Strong background and experience in laboratory and manufacturing operations. • Knowledge of cGMP in the pharmaceutical industry.

Company DescriptionFounded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.Company DescriptionFounded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money.

Synkriom leads the industry with experience authentication of candidates.

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