Validation Consultant
- Brentford, (GBR)
- Negotiable
- 6 Months
- Start date: ASAP
- Ref: GSK0JP00074025
- system testing
- SW Testing
- validation
- pharmaceutical
- documentation
- internal compliance
- change controls
- gap analysis
- quality management
- document management
- automated testing
- sops
- gmp
- debugging
Description:
Validation Consultant Level of knowledge/expertise:
Job Profile:
Tests a complete system or unit on new or revised programs to determine if all data is properly processed.
* Knowledge of both manual and automated testing.
* Support validation efforts by debugging software on simulators and diagnostic instruments. Knowledge of software testing with the ability to follow written procedures.
* Must be detail oriented to identify discrepancies between actual and expected results.
* Strong verbal and written communication skills.
The Validation Consultant is also responsible for creating and/or operating key departmental processes and procedures, acting as a departmental QMS expert and co-ordinating system IT Continuity tests.Specifically, the Validation Consultant will be responsible for:
- authoring departmental documentation (new processes e.g. Document Management Plan, etc)
- operating and maintaining key departmental processes (including documentation) such as Change Control, Self Inspection programme (schedule and checklist), Risk Log and Document Index acting as Change Control, Document Index and Self Inspection Administrator for departmental processes
- performing new departmental QMS Reviewer role (review/gap analysis/approve local SOPs against Global policies and procedures)
- creating, maintaining and co-ordinating Site IT Systems Continuity Test Schedule review and updating Site IT Continuity Plan, as required
- co-ordination of records retention policy within the department Essential Proven capability in writing documentation (e.g. project, support, departmental, etc)
Demonstrable understanding of Change Control and Document Management processes
Ability to coordinate complex tasks between various departments and personnel (including developing plans, coordinating effort, resolving issues and ensuring compliance to all relevant standards and methodologies) to implement new ways of working
Ability to work under minimal supervision
Ability to assess priorities and work well under pressure in a fast paced environment
Proficient with standard desktop tools
Previous involvement within the Pharmaceutical environment (GMP and/or 21 CFR part 11)
Desirable Exposure to working within Quality Management Systems Familiar with principles of IT Continuity System Testing Previous involvement in technical support environment (e.g. 1st or 2nd line support)
- Tests a complete system or unit on new or revised programs to determine if all data is properly processed.
- Knowledge of both manual and automated testing.
- Support validation efforts by debugging software on simulators and diagnostic instruments.
- Knowledge of software testing with the ability to follow written procedures.
- Must be detail oriented to identify discrepancies between actual and expected results.
- Strong verbal and written communication skills.
- Responsible for creating and/or operating key departmental processes and procedures, acting as a departmental QMS expert and co-ordinating system IT Continuity tests.
Specifically, the Validation Consultant will be responsible for:
- Authoring departmental documentation (new processes e.g. Document Management Plan, etc) operating and maintaining key departmental processes (including documentation) such as Change Control, Self Inspection programme (schedule and checklist), Risk Log and Document Index acting as Change Control, Document Index and Self Inspection Administrator for departmental processes performing new departmental QMS Reviewer role (review/gap analysis/approve local SOPs against Global policies and procedures) creating, maintaining and co-ordinating
- Site IT Systems Continuity Test Schedule review and updating Site IT Continuity Plan, as required co-ordination of records retention policy within the department
- Essential Proven capability in writing documentation (e.g. project, support, departmental, etc)
- Demonstrable understanding of Change Control and Document Management processes
- Ability to coordinate complex tasks between various departments and personnel (including developing plans, coordinating effort, resolving issues and ensuring compliance to all relevant standards and methodologies) to implement new ways of working
- Ability to work under minimal supervision
- Ability to assess priorities and work well under pressure in a fast paced environment
- Proficient with standard desktop tools Previous involvement within the Pharmaceutical environment (GMP and/or 21 CFR part 11)
Desirable
- Exposure to working within Quality Management Systems Familiar with principles of IT Continuity
- System Testing Previous involvement in technical support environment (e.g. 1st or 2nd line support)
CVs must be submitted in the first instance.
All CVs will be reviewed and considered for other relevant roles.
Deadline for CVs is Wednesday @ 10am
