QA IT Lead -SME
QA IT Lead -SME
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Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Ensure IT processes and procedures meet Quality System requirements.
- Participate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives.
- Support the development review and approval of Quality Assurance Agreements (QAA) along with the Approved Supplier List (ASL) process.
- Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects.
- Ensures new systems/processes/procedures are compliant with SOPs WIs and data and regulatory guidelines for IT and Software validation process.
- Assist in resolution of inspection management concerns as it relates to software applications process procedures and data integrity.
Requirements:
- Bachelors degree in a relevant field (e.g. Life Science Computer Science Engineering Information Technology) preferred.
- 100% Pharma Manufacturing at least the last 7 years Data Integrity Deviations GXP IT QA Systems hardware servers CAPAs SOPS Training Audits FDA ALL PRECSV Validation.
- This is not TESTER or Validations role.
- The Senior QA Specialist will serve as SME by supporting investigations risk assessments and IT Operations while verifying that GxP computerized systems operate as expected postvalidation.
- 7 years of experience in IT Computer Science Engineering or Chemistry in an FDA regulated manufacturing environment.
- Thorough understanding of IT CSV and QA IT roles and responsibilities in support of GxP compliance is required.
- Experience working in an FDA regulated environment with a strong emphasis on a riskbased approach to validation/qualification.
- Strong knowledge of FDA CFRs Eudralex and other biotech/pharma industry regulations (pertaining to IT laboratory systems automation and manufacturing).
- Strong knowledge of Data Integrity System Development Life Cycle (SDLC) validation methodology and Software Quality requirements.
- Understanding of root cause analysis and risk management techniques.
- Experience with quality management systems including change control incident management and deviation management.
- Strong Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation e.g. laboratory equipment facilities utilities manufacturing equipment information systems etc.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
