Business IT project manager – CSV
SGS
Business IT project manager – CSV
Job Description
Description
Your mission:
MANAGE INDEPENDENTLY COMPUTERIZED SYSTEM VALIDATION PROJECTS WITHIN A GMP GLP BUSINESS ENVIRONMENT
- Create detailed project planning and project teams.
- Establish and follow the budget.
- Coordinate and follow all project tasks and make sure progresses are made.
- Try to solve and report potential issues and problems.
- Collaborate with regional IT for projects development and implementation.
KEY BIT REPRESENTATIVE IN MULTIDISCIPLINARY PROJECTS
- Prepare / collect the URS and Functional specifications.
- Outline Test and validation plan / protocols / test cases.
- Perform or witness test executions.
- Write validation reports and procedures.
- Manage / Perform Periodic Reviews to ensure the system stays in a validated state.
ENSURE AND ORGANIZE BUSINESS APPLICATIONS FUNCTIONAL SUPPORT
- Work with the managers of the site to define the super users – and back ups
- Manage the change control requests and interface with regional IT
Qualifications
Your profile:
QUALIFICATIONS/EDUCATION
- University degree in (life) sciences with affinity for Information Technology or university degree in Information Technology with affinity for (life) sciences or equivalent experience.
- Languages: French / English
EXPERIENCE
- Very good knowledge on computer system validation, GAMP, 21 CFR Part 11 and other related regulations.
- Proven experience as an independent validation project leader in the pharmaceutical industry, preferably GMP GLP.
SPECIFIC REQUIREMENTS AND/OR COMPETENCES
- Good knowledge and big interest in IT
- Flexibility / Good planner / Team player / Good communication and reporting skills
Additional Info
- Perm contract
- Full Time
- Attractive salary
- Company car and other advantages
Company Description
SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 97 000 people and operates a network of more than 2 600 offices and laboratories around the world.
SGS Life Sciences is a leading contract research organization offering Clinical Research Drug Development and Quality Control/Laboratory Testing Services to the pharmaceutical and biopharmaceutical industry. It provides outsourcing services on both the quality and safety of drug ingredients and the drug development process – from the early development stages until the commercialization of the finished product.
To strengthen our Business IT team, we are currently looking for a Business IT manager – CSV
Locations
- Vieux Chemin du Poète 10, Wavre, Région Wallonne, Belgium (Remote)
Salary
90,000 - 150,000 EUR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Project planning and team managementintermediate
- Budget managementintermediate
- Computer system validation (CSV)intermediate
- GAMP and 21 CFR Part 11 knowledgeintermediate
- URS and functional specifications preparationintermediate
- Test protocol development and executionintermediate
- Change control managementintermediate
- Communication and reportingintermediate
Required Qualifications
- University degree in (life) sciences with IT affinity or IT degree with (life) sciences affinity (experience)
- Proven experience as independent validation project leader in pharmaceutical industry (GMP/GLP preferred) (experience)
- Very good knowledge of CSV, GAMP, 21 CFR Part 11 (experience)
- French and English languages (experience)
Responsibilities
- Create detailed project planning and project teams
- Establish and follow the budget
- Coordinate and follow all project tasks
- Prepare/collect URS and functional specifications
- Outline test and validation plans/protocols/test cases
- Perform or witness test executions
- Write validation reports and procedures
- Manage periodic reviews
- Work with site managers to define super users
- Manage change control requests
Benefits
- general: Perm contract
- general: Full Time
- general: Attractive salary
- general: Company car
- general: Other advantages
Answer 10 quick questions to check your fit for Business IT project manager – CSV @ SGS.
Business IT project manager – CSV
SGS
Business IT project manager – CSV
Job Description
Description
Your mission:
MANAGE INDEPENDENTLY COMPUTERIZED SYSTEM VALIDATION PROJECTS WITHIN A GMP GLP BUSINESS ENVIRONMENT
- Create detailed project planning and project teams.
- Establish and follow the budget.
- Coordinate and follow all project tasks and make sure progresses are made.
- Try to solve and report potential issues and problems.
- Collaborate with regional IT for projects development and implementation.
KEY BIT REPRESENTATIVE IN MULTIDISCIPLINARY PROJECTS
- Prepare / collect the URS and Functional specifications.
- Outline Test and validation plan / protocols / test cases.
- Perform or witness test executions.
- Write validation reports and procedures.
- Manage / Perform Periodic Reviews to ensure the system stays in a validated state.
ENSURE AND ORGANIZE BUSINESS APPLICATIONS FUNCTIONAL SUPPORT
- Work with the managers of the site to define the super users – and back ups
- Manage the change control requests and interface with regional IT
Qualifications
Your profile:
QUALIFICATIONS/EDUCATION
- University degree in (life) sciences with affinity for Information Technology or university degree in Information Technology with affinity for (life) sciences or equivalent experience.
- Languages: French / English
EXPERIENCE
- Very good knowledge on computer system validation, GAMP, 21 CFR Part 11 and other related regulations.
- Proven experience as an independent validation project leader in the pharmaceutical industry, preferably GMP GLP.
SPECIFIC REQUIREMENTS AND/OR COMPETENCES
- Good knowledge and big interest in IT
- Flexibility / Good planner / Team player / Good communication and reporting skills
Additional Info
- Perm contract
- Full Time
- Attractive salary
- Company car and other advantages
Company Description
SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 97 000 people and operates a network of more than 2 600 offices and laboratories around the world.
SGS Life Sciences is a leading contract research organization offering Clinical Research Drug Development and Quality Control/Laboratory Testing Services to the pharmaceutical and biopharmaceutical industry. It provides outsourcing services on both the quality and safety of drug ingredients and the drug development process – from the early development stages until the commercialization of the finished product.
To strengthen our Business IT team, we are currently looking for a Business IT manager – CSV
Locations
- Vieux Chemin du Poète 10, Wavre, Région Wallonne, Belgium (Remote)
Salary
90,000 - 150,000 EUR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Project planning and team managementintermediate
- Budget managementintermediate
- Computer system validation (CSV)intermediate
- GAMP and 21 CFR Part 11 knowledgeintermediate
- URS and functional specifications preparationintermediate
- Test protocol development and executionintermediate
- Change control managementintermediate
- Communication and reportingintermediate
Required Qualifications
- University degree in (life) sciences with IT affinity or IT degree with (life) sciences affinity (experience)
- Proven experience as independent validation project leader in pharmaceutical industry (GMP/GLP preferred) (experience)
- Very good knowledge of CSV, GAMP, 21 CFR Part 11 (experience)
- French and English languages (experience)
Responsibilities
- Create detailed project planning and project teams
- Establish and follow the budget
- Coordinate and follow all project tasks
- Prepare/collect URS and functional specifications
- Outline test and validation plans/protocols/test cases
- Perform or witness test executions
- Write validation reports and procedures
- Manage periodic reviews
- Work with site managers to define super users
- Manage change control requests
Benefits
- general: Perm contract
- general: Full Time
- general: Attractive salary
- general: Company car
- general: Other advantages
Answer 10 quick questions to check your fit for Business IT project manager – CSV @ SGS.