CSV Senior Compliance Advisor
CSV Senior Compliance Advisor
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Job Description
Every day our products improve the lives of millions of people around the world. Were hugely proud of this which is why were transforming our business to reach millions more. Join us on our journey to #ForeverCaring as a CSV Senior Compliance Advisor and youll drive progress that really means something.
The Computer Systems Validation (CSV) Senior Compliance Advisor will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure are validated or qualified in accordance with corporate quality standards.
Key Responsibilities
The CSV Senior Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection but also confirm that the delivered systems/services are fit for purpose by meeting user requirements.
Your Contributions (include but are not limited to):
Implementation Projects:
Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk-based validation approach for the system
Work closely with the Project manager to ensure all compliance milestones are met during the project lifecycle.
Oversee and/or assists in the development of validation deliverables including Validation Plans Test Plans/Protocols/Scripts Specifications and Design Documents Compliance Assessments Risk Assessments Installation Qualification System and User Acceptance Testing Data Migration Plans Traceability Matrices Validation Reports Supplier Assessments etc.
Prepare or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.
Establish and maintain standards and training materials for the specification design development configuration implementation validation use and maintenance of computerized systems which support the development manufacture and distribution of products in alignment with applicable company policies and regulations.
Coach the implementation teams in the proper execution of validation documents
Manage formal testing of computerized systems including setup of testing documentation approval delivery and test reporting.
Solve problems during validation process and address/advise on issues such as deficiencies deviations and change controls. Ensure initiation/preparation and closeout of all CSV related deviations.
Supply accurate KPIs to management on Project compliance status
System Maintenance:
Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change.
Ensure all changes are implemented and documented in a compliant manner.
Perform periodic assessment to review and confirm validated status.
Perform periodic re-validations.
Quality Management:
Ensure initiation/preparation and closeout of all CSV related deviations discrepancies and change control documents.
Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality to uncover errors or deficiencies in processes and deliverables and to identify strengths and opportunities for improvement.
Follow up resolution of identified quality exposures and escalation to team lead if critical situations are not resolved in due course.
Ensure that suppliers of IT services and solutions are properly assessed to determine their level of competence and reliability and ensure the organization employs appropriate risk based approaches to delivery taking into account the output of the supplier assessment.
Maintain up to date knowledge of evolving regulatory requirements availability of current/new techniques and literature regarding compliant computer systems and acts as an information resource for the delivery teams and wider business.
Skills & Experience
Strong understanding of GXP Regulations and best practice (21CFR820 21CFR11 Annex 11 GAMP etc.)
Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products.
Detailed understanding of computer system validation and infrastructure qualification including the application of risk managed approaches.
Experience in electronic software applications such as Electronic Document Management System (EDMS) Product Lifecycle Management (PLM) Quality Management Systems (eQMS) Complaint Management Systems Enterprise Resource Planning systems (ERP) etc.
Ability to rapidly adapt to new situations and environments.
Excellent communication skills with the ability to effectively convey compliance requirements at all levels.
Ability to influence negotiate and constructively challenge to achieve productive solutions.
Ability to handle a high concentration of work through successful multitasking & prioritizing.
Conscientious and highly committed with a dedication to quality.
Qualifications/Education
Bachelors degree in computer science engineering life science or related field.
5 years experience with CSV validation lifecycle management and validation documentation development.
Minimum 2 years experience with CSV process validation QA or compliance functions in pharmaceutical or Medical Device industry.
Excellent understanding and experience with industry regulations standards and guidelines e.g. GxP validation 21 CFR Part 11 etc.
Excellent presentation and writing skills.
Travel Requirements
Up to 10% travel within Europe (may require overnight stays).
Working Conditions
Hybrid 1 day per week in the office (driven by business requirements as Convatec has a flexible approach to office working).
Our products make a big difference every day. So will your contribution. The work you do will mean more because itll make things better for your team our business or our customers lives. Itll inspire you to deliver to your very best. And well be right behind you when you do.
This is a challenge more worthwhile.
This is work thatll move you.
#LI-AC2
#LI-Hybrid
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race religion creed color national origin nationality citizenship ancestry sex age marital status physical or mental disability affectional or sexual orientation gender identity military or veteran status genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec employee
If you are an active employee at Convatec please do not apply here. Go to the Career Worklet on your Workday home page and View Convatec Internal Career Site - Find Jobs. Thank you!
Required Experience:
Senior IC
Employment Type
Full-Time
