Pharmaceutical Validation Manager

5 days left

Recruiter
Anonymous
Location
Hertfordshire
Salary
55000.00 - 70000.00 GBP Annual + GBP55000 - GBP70000/annum
Posted
03 Sep 2017
Closes
01 Oct 2017
Function
Consultant
Contract Type
Permanent
Hours
Full Time
International Pharmaceutical Manufacturer requires a Validation Manager to take responsibility for key aspects of the day-to-day operation of the Validation Compliance Unit, and to maintain the Validation policy and Site Validation Master Plan in accordance with cGMP and industry standards and establish site wide compliance.

Duties will include:

• To ensure that all routine requalification and new validation activities are carried out in accordance to the Validation Policy and Site Validation Master Plan

• To determine the procedures to be used on validation exercises and projects according to GMP and Regulatory requirements and to manage the overall implementation of these exercises and projects.

• To chair the monthly Site Validation committee meetings and produce the minutes. To provide validation metrics to the Quality Management Review meetings. To provide deviation report corrective and preventative action (CAPA) information to the CAPA Review Board.

• To ensure that up to date authorised documentation is generated in a timely manner for all routine and non routine validation exercises

• To ensure that up to date authorised documentation is generated in a timely manner for all validation exercises and projects for which the post holder is responsible.

• To investigate, develop and implement improvements to validation templates and procedures.

• To advise on validation requirements necessary to maintain compliance with current GMP and regulatory requirements across site.

• To liaise and co-operate with other departments to carry out validation process improvements and changes as necessary to meet cGMP and regulatory requirements.

• To ensure compliance with Health and Safety and Environmental requirements.

• To ensure that all VCU validation equipment is maintained and calibrated in a timely manner, to agreed standards.

• To propose and agree Revenue and Capital Budgets necessary to carry out the agreed validation programme and to operate within those agreed budgets.

• Other tasks as necessary to maintain the effective functioning of the Validation Compliance Unit as required by the Technical Director