Computer System Validation Specialist at Halden Pharma

We are looking for a Computer System Validation Specialist at Halden Pharma

Position Overview:
The CSV Specialist will be responsible for designing, implementing, and executing CSV strategies and activities in compliance with regulatory requirements and industry standards. This position will be reported to the IT Manager in the Technical Department.

Responsibilities:

• Develop and implement CSV strategies, plans, and protocols for pharmaceutical computerized systems.
• Conduct risk assessments and gap analyses to identify areas for improvement in CSV processes.
• Perform validation activities, including IQ, OQ, PQ, and performance qualification (PQ) of computerized systems.
• Provide expertise and guidance on CSV regulations and guidelines, such as GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
• Collaborate with cross-functional teams to ensure alignment of CSV activities with project timelines and objectives.
• Prepare and review validation documentation, including validation plans, protocols, reports
• Support audits and inspections by regulatory authorities and clients, ensuring compliance with applicable regulations and standards.
• Stay informed about emerging trends and best practices in CSV and contribute to continuous improvement initiatives within the organization.
• Supports the CSV deliverables of periodic reviews collaborating with cross-functional teams. Identifies and reports any deviations or non-conformance findings.
• Develops, reviews and/or revises policies, procedures, and guidelines for the CSV Program. Identifies gaps and improvement areas in the CSV Program and proposes solutions to address them.

Qualifications:

• Bachelor's or Master's degree in engineering, computer science, or a related field.
• Minimum of 5 years of experience in CSV within the pharmaceutical or biotechnology industry.
• In-depth knowledge of CSV regulations, guidelines, and standards, including GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
• Experience in designing and executing CSV activities for a variety of computerized systems, such as laboratory information management systems (LIMS), manufacturing execution systems (MES), and electronic document management systems (EDMS).
• Strong analytical and problem-solving skills, with the ability to assess complex systems and identify compliance risks.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal teams and external stakeholders.
• Proven ability to manage multiple projects simultaneously and deliver results within established timelines.

Personal characteristics

• Positive mind-set and have an including attitude
• Good communication- and cooperation skills, and ability to communicated between different levels of the organization.
• Proactive and goal oriented
• Organized and quality oriented
• Ability of making decisions

What we offer:

• A healthy balance between work and leisure with flexible working conditions
• Excellent pension and health insurance schemes
• Opportunities to participate in activities organized by the company's sports club
• Access to our corporate cabins at Tanumstrand

Please contact Marcin Krzysztof Artuna if you have any questions related to the position: Marcin.Artuna@halden-pharma.com

If you are interested in the role, please send your application from SF-Careers.

Applicants will be considered on an ongoing basis.