Head of Validation

Recruiter
Anonymous
Location
South West England
Salary
60000.00 - 80000.00 GBP Annual + GBP60000 - GBP80000/annum
Posted
03 Feb 2017
Closes
18 Feb 2017
Function
Consultant
Contract Type
Permanent
Hours
Full Time
Role; Head of Validation

Location; South West

Salary; GBP60,000-GBP80,000 + Car Allowance + Benefits

The Role:

Reporting directly to the Quality Director and General Manager you will lead an experienced a team of validation Specialists and Engineers.

The role will be to maintain the qualification & validation status of all processes and systems in support of new, transferred, and existing products through definition & maintenance of methodologies & standards.

You will liaise with the Production and Quality departments, working closely with them to deliver effective solutions and drive change and improvement initiatives.

Main Duties include:

- Management of the Qualification / Validation Group
- Responsibility for the Qualification and Validation "system" and methodology
- Responsibility for the Site Validation Master strategy
- Responsibility for planning, coordination, execution and follow-up of qualification and validation activities
- Accountability for the performance against the Site VMP
- Contribute to maintaining and periodically evaluating the qualification/validation/part11 status of equipment, systems, products and processes
- Represent the Validation department during internal and external audits for qualification/validation of "operational" equipment, systems, products and processes
- Responsibility for the validation budget including costs charged to projects / clients
- Responsibility (indirect) for Qualification of laboratory equipment
- Active involvement in the introduction of new products, new processes, new equipment and new systems

Ideal candidates will have a degree and have a strong working knowledge of the principles and guidelines for GMP as set out in the 'Orange Guide.` You will have experience in a Pharmaceutical Production environment under GMP regulations (e.g. Production, Product Introduction, Engineering, Quality Assurance) and have knowledge of typical pharmaceutical production processes, equipment and systems. To be successful in the role knowledge of the concepts, legislation, guidelines and requirements related to qualification and validation of products, processes, equipment and systems, including Computer System Validation and Part11 is essential. Knowledge of GMP requirements and pharmaceutical legislation is essential and the successful candidate must be compliance driven. A proven track record and the capability of leading cross functional teams is essential for the
role.





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