Responsibilities
- Provide independent technical leadership and accountability for overall computer system validation efforts.
- Ensure quality and compliance in accordance with established procedures and standards of the Quality Systems by applying critical thinking on CSV work
- Generate, review and approve base level document such as Validation Plan, URS, FRS, DS, and SOPs in support of Computerized System Validation/Assurance activities
- Generate, review/approve and executing computer validation (IQ, OQ, and PQ) documentation for GxP systems from Quality Control Units
- Develop, implement and maintain computer system validation-related controlled documents to support the initiation, validation, operation and maintenance of GxP systems.
- Assist with change controls, CAPAs, deviations, exceptions required as part of system validation efforts
- Support system administrative & maintenance activities for Lab Systems
- Support continuous improvement efforts by monitoring, tracking and performing the steady state activities for Lab Systems
- Perform gap analysis & necessary remediation efforts on current computer systems to ensure compliance with Part 11 and Annex 11.
- Collaborate/lead/participate in decision-making and make recommendations regarding the best options for validation of computer systems. Maintain close communication with stakeholders and team members to keep apprised of computer system needs, impact on computer system validation, project validation status, and other relevant issues
- Collaborate with approved vendor personnel in coordinating validation efforts including reviews/approvals of related validation deliverable and for ensuring a successful validation lifecycle.
- Reviews department-specific SOPs periodically and updates if/as needed to ensure that the procedures are always up to date based on the latest regulatory updates and industry best practices.
- Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted.
- Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk assessments, & System and Data Audit Trail assessments, etc.
Minimum Required:
- Minimum of Six (6-8) years or more in the pharmaceutical industry with GMP experience.
- Understanding phases of Life Cycle Validation approach and practical working knowledge of computer system validation/computer software assurance requirements.
- Knowledge of validation of cGMP automation/computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
- Demonstrate ability to effectively manage multiple projects/priorities
- Demonstrate excellent written and oral communication skills.
- Effective time management and interpersonal skills.
- Must work effectively within teams with rapidly changing priorities.
- Demonstrates analytical problem-solving skills.
Preferred:
- Relevant validation experience with Laboratory systems used within the pharmaceutical industry is a plus
Minimum Required
Bachelor's degree in Engineering, Science or a related technological field
Preferred
Bachelor's degree in Pharmaceutical Science, Bio-medical Engineering, or Management of Information Systems (MIS)
