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Senior Validation Specialist
3 weeks ago
Job Description
">- Provide project management oversight from a Quality perspective for FUE activities related to products and facilities, utilities, equipment (FUE).
We are seeking a highly skilled QA Validation Associate to join our team at Claran Consultants Ltd. As a key member of our team, you will be responsible for the review and approval of validation lifecycle activities in a GMP regulated environment.
">Responsibilities
">Assist Functional Validation groups in the development of validation plans for specific system implementation projects.
Review and Approval of project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
Requirements
">- A Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
Desirable Skills and Experience
">- +5 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
- Experience with QA Oversight of Project activities QA Oversight / Execution of HVAC / Utilities qualification QA Oversight / Execution of Computer Systems Validation with focus on Data Integrity Organizational and management skills to coordinate multi-discipline project groups Ability to speak, present data, and defend approaches in front of audiences and inspectors.
About Us
">Claran Consultants Ltd is a leading provider of consulting services to the biotech industry. We pride ourselves on our expertise and dedication to delivering high-quality results to our clients.
