Reporting directly to the Director of Quality, Packaging & Compliance, the jobholder is responsible for providing effective leadership and quality oversight for all aspects of the validation and qualification process and activities across site. This includes Equipment, Facility, Utility, Cleaning, Computer system & shipper qualification activities.
The role may also require involvement in executing validation and qualification activities.
The role will be responsible for assuring compliance with all relevant legislation and maintaining a best in class quality system ensuring that Quality Assurance is integral to the business strategy (3-Year outlook) and ‘fit for purpose’ in delivering on Business Goals.
- To ensure that all routine requalification and new validation activities are carried out in accordance to the Validation Policy and Site Validation Master Plan and in line with documentation timelines.
- To determine the procedures to be used on validation exercises and projects according to cGMP and Regulatory requirements and to manage the overall implementation of these exercises and projects including execution of protocols where required.
- To chair the Site Validation committee meetings and produce the minutes.
- To track, trend and report on all validation/qualification and change control related metrics monthly and quarterly for management review.
- 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, co-operate and train 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 propose and agree Revenue and Capital Budgets necessary to carry out the agreed validation programme and to operate within those agreed budgets.
- To act as Qualification and Validation SME in client audits and regulatory inspections
- Manage a team of people both reporting directly and indirectly into this role.
- Other tasks as necessary to maintain the effective functioning of the Validation teams across site as required by the Quality Director.
- Act as the Quality Lead for one or more major revenue earning clients.
- To ensure the team provides quality management of the change control process and Maximo equipment maintenance system.
- To participate and chair where required the weekly change control meetings.
- Act as Delegate for Senior QA Manager/ Quality Director as required
- To undertake additional duties as directed and agreed with the Director, Quality.
Minimum Requirements/Qualifications: (Bullets)
- Extensive knowledge of GMP environments.
- Teamwork especially in a matrix management organisation.
- Ability to influence across functions across Fisher sites and across companies to achieve objectives.
- Process analysis skill suitable to collect/analyse data leading to proposed process improvement with quantifiable business benefit.
- Experience gained at a middle management level within a pharmaceutical environment.
- Flexible and adaptable, with strong customer management skills. Must be highly responsive whilst maintaining strategic direction. Needs to be comfortable with ambiguity.
- Able to analyse problems and define solutions.
- Good communication skills both internally and externally.
Non-Negotiable Hiring Criteria: (Bullet 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.)
- Degree Level or Equivalent in relevant subject or minimum of 3 years’ experience within Validation and Qualification management role
- Professional Qualifications within the quality arena