Lead Validation Analyst

How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.
CIBA Vision is a global leader in the research, development and manufacturing of contact lenses and lens care products. Headquartered in Atlanta, Georgia, we provide solutions that fit the lifestyles, preferences and needs of people in more than 70 countries around the world. From fun to essential, disposable to permanent, new eye colors to new eye treatments - CIBA Vision offers alternatives to your vision needs.

We seek to hire a Lead Validation Analyst.

POSITION PURPOSE:

Act as validation lead of the Legacy systems project and support Global Applications from a QA standpoint. Validation, change control and QA activities must be conducted according to FDA, Novartis and project directives. Prepare, review, approve and in some cases execute associated validation protocols and related documents. Project Management activities will include organizing the validation teams, driving user and technical documentation, tracking deviations and reporting on the progress of the project to management.

PRIMARY RESPONSIBILITIES:

Prepare, review, approve and execute validation protocols for computer systems validation projects.

Provide Project Management leadership to the computer systems validation projects.

Review of high level quality concepts, plans and documents of global systems, projects and applications.

Qualifications
Education:

BS Engineering / MIS / CS

Experience:

6-9 yrs overall related experience, to include:

3-4 years experience in computer systems validation.

Experience in cGMP, Knowledgeable of 21 CFR Part 11 and FDA regulations.

Skills:

Knowledgeable of cGMP, 21 CFR Part 11 regulations and FDA regulations with regards CSV.

Must have performed/lead Computer System Validation in the Medical Device or Pharmaceutical industry.

Good technical writing and communication skills. Good PC skills.

Preferred level:

MS Engineering / MIS / CS / MBA

Preferred Level:

9+ yrs overall related experience, to include:
3-5 years experience in Computer Systems Validation in pharmaceutical or Medical Device industry. Experience in project management and quality systems. Experience in cGMP, SOX, FDA, strong knowledge of 21 CFR Part 11 regulations.

Preferred Level:

Expert knowledge of cGMP, 21 CFR Part 11 regulations and FDA regulations with regards CSV.
Excellent technical writing skills. Excellent communication and project management skills. Good documentation management skills. Excellent PC skills.
Must have performed/lead Computer System Validation in the Medical Device or Pharmaceutical industry.
Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.
REQUIREMENTS
Please see Job Description