Paga: 81,000 mas salario complimentario
Tiene que tener experiencia en validaciones de sistemas computarizados (CSV)
Turno administrativos (con todos los if... si es necesario turnos extendidos y fines de semana). Los top 4 serian:
1. SME en el CSV Validation LifeCycle
2. Proficient validation protocol writting skills
3. Knowledge of FDA Part 11, 211.68, Data Integrity for Computerized Systems regulations
4. Experience with CSV remediation projects. That is experience in evaluating missing CSV tests in a validation and the know how to remediate and execute those missing steps or tests.
MINIMUM REQUIREMENTS
Performs computerized systems validation for Client manufacturing facility’s cGMP IT systems, manufacturing automated process control systems and equipment according to all Federal, International, State and Corporate Regulations. Responsible for the design, development and execution of software & computer validation protocols and computer validation plans, for the manufacturing operations. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Works with the site’s IT Computer System Validation BMS Personnel and the site’s QA/QC management in development and execution of Software/Computer Validation plans for automated equipment, processes, and systems.
2. Identifies computerized systems validation needs through in-house assessments.
3. Develops Software/Computer Validation Protocols according to BMS policies on computerized systems validation. .
4. Coordinates and executes activities as per approved Protocol.
5. Recommends acceptance of the computer software, as determined from the tests performed on the Protocol. Analyzes data in order to determine acceptability. Recommends actions to be taken if the software is not accepted.
6. Generates Final/Validation Report in accordance with actual FDA certification concepts.
7. Advises the IT Director on the adequacy/completeness of Software Operational Qualification Protocols for his/her approval.
8. Promotes and supports Plant’s Safety, cGMP and SOP programs.
9. Maintains close communications with Site plant projects to keep abreast of computerized system needs and impact on computer validation.
10. Performs computerized systems validation in conformance with cGMP's, plant procedures, corporate policies, and applicable regulations (FDA, DEA, etc.)
MINIMUM REQUIREMENTS
Bachelor Degree in Computer/Software, Industrial, Mechanical Engineering or Electrical Engineering. * Training in validation methodologies, technologies and process control computer systems. * Three (3) years of experience in computer systems. * Through knowledge of cGMP and FDA regulation is a must. * Excellent communication skills (oral, written and reading) in Spanish and English at all levels * Proven skills in projects management and validation of manufacturing and quality related systems. * Knowledge of manufacturing equipment and processes (e.g. Packaging, Tablet Press, etc.) a must. * Able to work under pressure * Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.
Job Type: Full-time
Salary: $80,000.00 to $81,245.00 /year
Experience:
Computer System Validation: 3 years (Required)
Pharmaceutical: 3 years (Required)
Benefits:
None
Schedule:
Monday to Friday
