Job Details: CSV Manager
| Job Title: | CSV Manager |
| Company: | Reliance One, Inc |
| Position Type: | Permanent |
| Pay Rate: | $90-100K |
| Date Posted: | Jul-08-08 |
Years of Experience:
• 5+ years of software validation and Part 11 compliance experience.
• Previous hands on experience authoring validation plans, test plans, test scripts and summary reports is required along with executing and documenting test scripts and deviations.
• 3+ years of management experience desirable.
• Pharmacy systems experience a plus.
Job Description:
• Qualified candidate will lead/oversee/participate on corporate teams (current group consists of 3 CSV Specialists) regarding system validation, quality assurance, quality engineering and regulatory compliance process and operational improvements regarding computerized systems.
• Lead software quality assurance validation efforts and system compliance to federal regulations (e.g. 21 CFR Part 11, cGxP, etc) and set overall strategic vision for multiple sites.
• Communicate risk and compliance issues regarding computerized systems validation and vendor audits to Management. Foster communication and cooperation between software quality, software development, information technology, software support teams and the user community.
• Provide the Division with consistent leadership and guidance in the creation, interpretation and implementation of software quality systems and assure consistent interpretation and implementation of regulatory requirements and validation process improvement initiatives.
• Will promote continuous process improvements by initiating and supporting process improvements to reduce software validation costs and cycle time and promote risk-based validation process by ensuring the defined software validation policies and procedures are appropriate and followed for each system being validated.
• Additionally, the candidate will support projects and project portfolios while ensuring adherence to company project management standards and the timely delivery of CSV projects.
• Must possess an ability to work with users at different sites (US and global), strong analytical and risk assessment skills, and manage multiple projects.
Special Skills Required:
• Demonstrate outstanding customer support, oral and written communication, analytical and risk assessment skills.
• Life Sciences Industry experience desirable.
• Experience with IT systems a plus.
• Must understand the US and UK regulations as they apply to CSV with the potential to interpret other international CSV compliance regulations.
Educational Requirements:
• Bachelors of Science in Information Technology or related field.
| Location: [rss] | US-MI-Lansing |
| Telecommute: | No (Onsite Position) |
| Contact Name: | Gwen McDonald |
| Contact Phone: | 248.899.1003 |
| Contact Email: | gmcdonald@reliance-one.com |
Principals only. Recruiters, please do not contact this job poster.
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