Career Techniques Inc.
- Partner with key business stakeholders to develop policies and procedures necessary to lead/guide the implementation and maintenance of a compliant, efficient and integrated CSV program.
- Draft , review and approve validation deliverables such as user requirements, technical design specifications, IQ/OQ/PQ scripts and reports, error logs, configuration document, traceability matrix and document 21 CFR Part 11 and EU Annex 11 compliance.
- Perform gap analysis and implement SOP harmonization by aligning customer Quality Management System to ITIL and GAMP 5 guidelines.
- Provide structure and guidance to support the compliant implementation of computer systems.
- Facilitate, prepare and execute CSV documents for Technical Operations, QC, QA and R&D groups, as necessary
- Understand the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.
- Develop Test Plan, Test Cases, Test Reports and Traceability Matrix as per business requirements
- Manage end to end testing / validation lifecycle on applications likes - Solution Manager, JIRA, and HP ALM (desired)
- Provide SME support on topics relevant to GxP, CSV, 21 CFR Part 11, Annex 11 etc
- Coordinate with Information Technology and Business owners to ensure that GxP computerized systems and software are validated for their intended use.
- Evaluate risks, assess closure requirements, and process change controls for computerized systems.
- Maintain and implement quality systems to ensure compliance with applicable global regulatory requirements.
- Promote adherence to applicable policies and procedures governing computer systems, good documentation practices, and change management.
- Develop CSV Standard Operating Procedures (SOPs) and approve CSV SOPs, as required.
- Integrate life cycle management of computer systems, including infrastructure obsolescence, into operational planning for long term sustainability
- Enhance and implement document management and training plans for a compliant approach to the software development lifecycle (SDLC)
- Leading teams of 3-10 members
- Bachelor's/Master’s degree in Engineering, Science, Medical or related field
- 5-7 years of experience in computer systems validation and hands on experience within a GMP/GxP regulated environment (FDA, EU, MHRA)
- Strong working knowledge and experience of global regulations and guidelines such as GAMP, CFR Part 11 Annex 11 and other FDA regulations i.e. 21 CFR Part 210, 211, Part 820, ICH Q9, QSRs, ISO 13485, HIPPA etc. coupled with ability to practically apply such knowledge
- Demonstrated knowledge of validation requirements of control systems in a GMP and/or ASTM environment
- Strong knowledge of industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
- Proven experience developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC or Agile phases
- Experiences working with Pharma/Biotech implementation of R&D systems, preferably including translational and late research systems
- Define risk-based strategies for validation of computerized systems and author review end-to-end CSV documentation in accordance with various test plans
- Perform system risk assessments - GxP, Business, and Functional Risk Assessment, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
- Understanding, preparing, and implementing CSV and project related SOP’s and WI’sWell versed in Good Documentation Practices
- Validation life cycle in Agile and other SDLC methodology
- A thorough understanding of drug development processes from discovery through development and post-marketing, with an ability to understand business requirements and translate them into practical solutions
- Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel
- Certification / experience in Operational Excellence / Six Sigma highly desired
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint)
- Good Verbal and non-verbal communication skills