Manager, Quality Assurance Software
Job Posting for Manager, Quality Assurance Software at Technical Resources International
Job Description
Job Requirements
Responsibilities
- Serves as the QA validation liaison
- Conduct risks assessments and review test scripts according to GMP and 21 CFR Part 11 compliance guidelines with the Validation Master Plan
- Revise and develop related SOPs
- Responsible for Information systems, information security, and software vendor related audits where applicable
- Conducts training on software validation
- Assist in the conduct of information systems, information security, and software vendor related audits where applicable
Requirements
- Bachelor’s degree in Science or Engineering required and a minimum of 7-10 years of experience in the pharmaceutical industry, or 7-10 years of relevant Validation experience working in the pharmaceutical industry
- Work well in cross-functional departments (IT, QA, etc.)
- Self-starter who exhibits a professional demeanor, enthusiasm and the ability to work independently with minimal supervision
- Sound knowledge and experience of medical device or pharmaceutical industry standards and requirements
- Knowledge of current industry expectations of validation requirements for process validation and computer system validation
- Knowledge of documentation standards for validation
- Ability to work effectively under pressure to meet deadlines
- Strong written and oral communication skills
- Strong knowledge of GAMP5 Validation Life Cycle, ICH E6 (R2) and 21 CFR Part 11
- Minimum 5 years of prior staff management experience
- Travel 10-15% when needed
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Salary.com Estimation for Manager, Quality Assurance Software in Bethesda, MD
$118,698 to $150,758
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Job openings at Technical Resources International
Technical Resources International
Bethesda, MD
Full Time
Technical Resources International
Bethesda, MD
Full Time
Technical Resources International
Bethesda, MD
Full Time
Technical Resources International
Bethesda, MD
Full Time
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