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QA Validation Engineer
Eingestellt von Morgan McKinley
Gesuchte Skills: Engineer, Engineering, Draw
Projektbeschreibung
QA VALIDATION ENGINEER
POSITION SUMMARY
- QA Validation Engineer will ensure that all key validation related documents are developed, executed and reviewed in accordance with GMP regulatory and corporate and internal requirements.
- The facility will encompass all steps to manufacture a finished product from incoming inspection of materials, manufacture of the finished product, sterilization, packaging and final testing/release to the distribution centres.
- The operation encompasses clean room technology, critical utility systems, advanced automation technology and in house laboratory testing and release.
MAIN DUTIES AND RESPONSIBILITIES
- Review/Approval of Validation Protocols ( eg URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
- Review/Approval of Validation Reports ( eg URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
- Resolve and assist in the closure of discrepancies initiated during Qualification execution.
- Ensures that change requests and Document Change Requests are compliant with all applicable procedures. This will involve actively reviewing the CR's and the underlying documents for compliance and the ability to be understood by third party reviewers.
- Responsible for providing feedback to the originators, approvers, and site management.
Develop/Review/Approve Validation Plans. - Implement, deploy and revise as applicable Validation procedures.
- Conduct training in Validation Methodologies and related procedures as required.
- Provide guidance to project teams on Validation strategy and approach.
- Generate SOP's/other documentation as applicable.
- Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11.
KEY SKILLS AND COMPETENCIES REQUIRED
- Ability to prioritize and manage the workload, and as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.
- Demonstrate excellent communication skills (verbal and written).
- Ability to develop and give presentations on technical and regulatory topics.
- Ability to train/mentor associates.
- Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
- Ability to read, analyze, and interpret complex technical documents and manuals.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
EDUCATION AND EXPERIENCE
- Minimum of degree qualification in relevant science and/or engineering discipline
- 3 Years minimum post educational experience with working in a regulated environment
- Preferably within a Pharma/Biotech facility.
5 years in a Validation function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations. - Have a strong working knowledge of statistical techniques in the use of problem solving/data analysis.
- Experience of coordination of Quality documentation and in particular, qualification/Validation documentation and using an electronic document management system.
POSITION SUMMARY
- QA Validation Engineer will ensure that all key validation related documents are developed, executed and reviewed in accordance with GMP regulatory and corporate and internal requirements.
- The facility will encompass all steps to manufacture a finished product from incoming inspection of materials, manufacture of the finished product, sterilization, packaging and final testing/release to the distribution centres.
- The operation encompasses clean room technology, critical utility systems, advanced automation technology and in house laboratory testing and release.
MAIN DUTIES AND RESPONSIBILITIES
- Review/Approval of Validation Protocols ( eg URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
- Review/Approval of Validation Reports ( eg URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
- Resolve and assist in the closure of discrepancies initiated during Qualification execution.
- Ensures that change requests and Document Change Requests are compliant with all applicable procedures. This will involve actively reviewing the CR's and the underlying documents for compliance and the ability to be understood by third party reviewers.
- Responsible for providing feedback to the originators, approvers, and site management.
Develop/Review/Approve Validation Plans. - Implement, deploy and revise as applicable Validation procedures.
- Conduct training in Validation Methodologies and related procedures as required.
- Provide guidance to project teams on Validation strategy and approach.
- Generate SOP's/other documentation as applicable.
- Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11.
KEY SKILLS AND COMPETENCIES REQUIRED
- Ability to prioritize and manage the workload, and as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.
- Demonstrate excellent communication skills (verbal and written).
- Ability to develop and give presentations on technical and regulatory topics.
- Ability to train/mentor associates.
- Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
- Ability to read, analyze, and interpret complex technical documents and manuals.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
EDUCATION AND EXPERIENCE
- Minimum of degree qualification in relevant science and/or engineering discipline
- 3 Years minimum post educational experience with working in a regulated environment
- Preferably within a Pharma/Biotech facility.
5 years in a Validation function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations. - Have a strong working knowledge of statistical techniques in the use of problem solving/data analysis.
- Experience of coordination of Quality documentation and in particular, qualification/Validation documentation and using an electronic document management system.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik