IT Quality Manager - Validation

Yoh has contract opportunity for an IT QUALITY MANAGER - VALIDATION to join our client at RTP, NC.

JOB OVERVIEW:

Our client is looking for pharmaceutical, manufacturing candidates. They are seeking someone who is very strong and experiences in reviewing, correcting and evaluating other people's validation work. This role is not one project specific, but working on a variety of projects at a given time. This person will be responsible for assisting the department in achieving their compliance and quality objectives.

JOB RESPONSIBILITIES:

- Review and perfect SDLC and SQA documentation to Company standards and

recommend corrections for regulatory compliance.
- Update IT operations and procedures for improved quality attributes.
- Evaluate the validation state of applications and assist with bringing excursions back into compliance.
- Collect and process information for IT Quality metrics.
- Assist with implementing IT Quality-related system improvements.

JOB QUALIFICATIONS:

- B.S. Degree required, Masters or above preferred
- Individual must have experience in a variety of regulations, not just US. (UK, Japan).
- Extensive experience (10 years) with manufacturing and quality applications

and automation systems in pharmaceutical manufacturing facilities
- Experience (7 years) with FDA cGxPs, 21 CFR Part 11, EMA Annex 11, PIC/S

computerized systems validation, and GAMP 5, as well as their application
to preparing defensible validation documentation
- Experience (5 years) with determining defensible SDLC and SQA approaches

to varied types of IT-related computerized systems
- Excellent writing and communications skills
- Must have Manufacturing operations and quality procedures experience in a variety of aspects.
- Must be experienced working on a variety of projects.

DISCOVER ALL THAT\'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Jack Taylor

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our Recruitment Process Outsourcing services.

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