CSV Manager
2 months ago
Position: CSV Manager
Location: King of Prussia (onsite)
Company: Sk Pharmteco
The Computer System Validation (CSV) Manager will be responsible for overseeing and managing the validation of computer systems and software applications to ensure compliance with regulatory requirements, industry standards, and company policies. This role involves planning, coordinating, and executing validation activities, as well as providing guidance and support to cross-functional teams.
Responsibilities:
- Develop and implement CSV strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g., FDA, EMA, GxP).Manage and lead the CSV team, providing guidance, training, and support to ensure the successful execution of validation activities.
- Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure the successful validation of computer systems and software applications.
- Plan, coordinate, and execute validation projects, including the development of validation plans, protocols, and reports.
- Conduct risk assessments to identify potential validation issues and develop mitigation strategies.
- Review and approve validation documentation, ensuring accuracy, completeness, and compliance with regulatory requirements.
- Monitor and track validation activities to ensure timely completion and adherence to project timelines.
- Stay current with industry trends, regulatory changes, and best practices related to computer system validation.
- Provide support during regulatory inspections and audits, including the preparation and presentation of validation documentation.
- Continuously improve the CSV process by identifying areas for enhancement and implementing best practices.
Requirements:
- Bachelor’s degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.
- Minimum of 5 years of experience in computer system validation within the pharmaceutical, biotechnology, medical device, or related industry.
- Strong knowledge of regulatory requirements and industry standards related to CSV (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11).Experience with the validation of a variety of computer systems, including ERP systems, LIMS, MES, and other software applications.
- Experience with Lab and Process Equipment computer system validation.
- Excellent project management skills, with the ability to manage multiple projects simultaneously and meet deadlines.
- Strong analytical and problem-solving skills, with a keen attention to detail.
- Effective communication and interpersonal skills, with the ability to collaborate and build relationships with cross-functional teams.
- Ability to work independently and as part of a team, with a proactive and results-oriented approach.
- Experience in managing and leading a team of validation professionals.
- Certification in computer system validation or quality management (e.g., ASQ, ISPE) is a plus.
Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.
SK pharmteco Inc., an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.
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