Manager, IT Computer System Validation
Bristol-Myers Squibb Company
Manati - PR - US
hace 20 días

Accountable for leading and managing IT Computer System Validation (CSV) strategy execution and CSV Team to assure site adherence to BMS Corporate CSV Directive and site procedures and methodology.

Also accountable for assuring a compliant and cost effective operation. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Responsibilities :

1. Ensures the development and maintenance of the Site Computer System Validation Master Plan strategy and methodology.

2. Manages the CSV execution plan, ensuring that validation and revalidation of projects implemented are up to date and sustainable.

3. Develops and implements an efficient Software / Computer Validation Compliance Program for Business, Mfg. System and Quality Systems equipment, processes, and systems.

4. Leads and manages the Risk Assessment document development to support validation strategies and decision making.

5. Manages and / or assists Corporate and Plant Quality Assurance Audit teams regarding inspection / audit support for the validation compliance and documentation of Business, Mfg.

System and Quality Computerized Systems.

6. Leads the detection and evaluation of systems deficiencies for the implementation of corrective actions which will assure correct operation of the systems and compliance to regulated agencies requirements.

7. Communicates to management potential systems situations which can affect quality or compliance to ensure that appropriate management action is taken to correct these problems.

8. Manages direct reports personnel hiring, performance management, training, development and career path and ensures a timely and adequate performance in conformance with cGMP’s, plan procedures, corporate procedures, and applicable regulations (FDA, EMEA, DEA, etc.

to maintain a technically competent and customer service oriented work team.

9. Manages and develops CSV resources.

10. Supports technically the implementation of computer systems and provides guidance to assure compliance with all regulatory requirements, company policies and procedures.

11. Ensures that the Computer Systems Validation and Quality Systems teams have the technology and infrastructure in place and operational, to support the site’s Mfg. operation.

12. Provides IT administration and support for standard business, quality systems as needed.

13. Provides project management and coordination for corporate, regional and site IT projects and initiatives.

14. Keeps all cGMP data and image communications systems operational and reliable, maintaining quick and accurate problem response, and maintaining a highly competent and technical support staff.

15.Seeks and promotes knowledge & awareness of new and emerging technologies and identifies opportunities for current applications under a Continuous Innovation Process commitment.

16. Establishes, harmonizes and maintains the necessary controls (SOPs, Policies and Procedures) that will ensure the effective utilization of IT Business, Mfg.

System and Quality Systems infrastructure & technical resources.

17.Ensures that system documentation such as : requirements, specification, drawings, qualification protocols and equipment manuals for the installation are properly maintained and securely kept.

18. Enforces Bristol-Myers Squibb Company hardware and software standards.

19. Determines work procedures, prepares work schedule and expedites workflow.

20. Ensures that there are approved standard operating procedures (SOPs) in place for the installation, use, and problem resolution of Business, Mfg.

System and Quality Systems communications hardware and software.

21.Visits vendors to learn about available products or services.

22.Identifies computerized systems validation needs through in-house assessments.

23.Provides guidance on Change Control Procedures and recommends action(s) to be taken whenever additions, alterations or changes are to take place in computerized process and member of the Site Change Control Committee.

24. Maintains close communication with Plant Management to keep abreast of new computerized systems needs or to enhance existing systems.

25.Implements and supports Global Manufacturing & Supply IT initiatives at the site.

26.Assists IT site Director with the development and management of the department budget.

27. Assists in the development and management of Capital Appropriation Requests (CAR’s) and timeline of IT projects and in prioritization of projects and schedules as needed.

28.Maintains a working knowledge and awareness of regulatory requirements and activities via appropriate government, professional and trade publications, courses of study and trade meetings.

29.Performs as the Site IT Subject Matter Expert for 21 Code of Federal Regulations (CFR) Part 11 compliance aspects.

Knowledge / Skill :

  • Bachelor Degree in Science, Computer Science or Engineering
  • Eight (8) years experience designing, testing, validating and implementing business systems, quality systems and manufacturing systems technology in a pharmaceutical industry environment
  • Three (3) years supervisory or managerial experience
  • Hands-on knowledge in computer systems validation life cycle methodologies
  • Skills in project management, infrastructure designs development and implementation
  • Skilled with Microsoft Office applications
  • Ability to impact and influence people / areas with outstanding results
  • Thorough knowledge of cGMP, FDA and EMEA regulations in pharma manufacturing environment
  • Excellent communication skills (oral, written and reading) in Spanish and English
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