Validation Specialist job in Memphis, USA

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First Name*

Last Name*

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Job type: Permanent

Discipline: Laboratory Technician, Pharmacokineticists, Pharmacology

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Validation Specialist with a pharmaceutical company located in Memphis, TN.

Job Responsibilities:

Responsible for helping to maintain the validation program including manufacturing, packaging, facilities, utilities, equipment, control systems, and processes at the Memphis facility. will generate validation documentation and plan validation projects.
Effectively resolve issues associated with validation efforts and represent that department during internal audits.
Responsible for the periodic trending of process capability data to ensure compliance with FDA standards.
Develop, implement, and maintain a continuous verification program to include periodic trending of process capability data including all necessary procedures.
Write and execute IQ, OQ, and PQ protocols and summary reports for the facilities/utilities, manufacturing, and packaging areas as needed.
Write and execute PV protocols and summary reports for product reformulations and New Product Introductions (NPIs).
Participates in Validation SOP development and the ongoing maintenance of the validated status of GXP systems.
Responsible for driving all aspects of the Validation Life Cycle in Packaging and Utilities/Facilities from design through operation and improvement.
Monitors validation criteria and assures compliance with written validation standards.
Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the validation working party.
Leads and ensures accountability to the site's Product Lifecycle Management governance process.
Support site during internal audits as required.
Comply with all local, state and federal EHS laws and regulations, and all Global EHS requirements.

Skills and Requirements:

Bachelor of Science or Bachelor of Engineering
Basic understanding of scientific or engineering discipline, validation or statistics
3-5 years of validation experience in pharmaceutical or consumer healthcare industry
Successful demonstration of validation experience within a pharmaceutical or consumer healthcare manufacturing environment designated as new product introduction site with new products, processes, and equipment are being introduced continuously.
Effective Strategic Communication skills -delivering written and oral communication with clarity and impact, tailored to the audience.
Strategic Customer Focus- taking initiative (a clearly interconnected set of activities) designed to raise the 'value added' for to ensure a wider or long term effect/benefit.

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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