QA IT Lead -SME

Job Description

Job DescriptionCompany Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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:

• Bachelor's 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, CAPA's SOPS Training Audits, FDA ALL PRE-CSV 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 post-validation.
• 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 risk-based 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.