looking for a strong SME - Software Validation for our direct healthcare client in PA. The ideal candidate should have at least 5-7 years of experience in software validation. Should have proven and strong hands-on knowledge of software validation/GAMP. The candidate will be strong in writing skills, including use of MS Word with excellent communication skills. The candidate will be responsible for creating and ensuring all computer validation master plans and computer system validation documentation meet current regulatory requirements, maintaining strict compliance with cGMPs, company SOPs and other state and federal regulations.
5 7 years plus experience in a professional IT environment
- Pharmaceutical experience required.
- Working knowledge of cGMP, GMP and 21CFR Part 11.
- Experience working with various departments including engineering and operations to provide a high degree of assurance that computer system implementations and upgrades are controlled and computer validations, where appropriate, are completed.
- Capable of effectively communicating, directing, guiding personnel who are not direct reports in various aspects of cGMPs.
- Familiarity with discussing Computer Validation with customers or regulatory agencies as required during reviews or inspections.
- Must have experience operating in a GMP environment.
- Must have experience with computer system lifecycle and risk-based validation.
- Must have working knowledge of GAMP 5.
- Must have working knowledge of SOX regulations.
- Technical qualifications: must be proficient in MS-Office (Word, Excel, PowerPoint).
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Please feel free to call me at 408-833-6257 or email at raj.talukdar @satincorp.com for further details.
SA Technologies - 24 months ago