Acorn Recruitment is seeking an interim Validation Specialist for a global pharmaceutical business in Cardiff, South Wales.
Rate per hour - £competitive
Duration of contract - 3 months
Working hours 38 - Monday to Thursday 08:00 - 16:30 and Friday 08:00 - 15:30
Enhance validation practice and compliance; support improvement to validation system; streamline processes. Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body etc. through routine compliance activities and specific validation projects
* Maintain all validation compliance activities in a timely manner in line with the Site Validation Plan.
* Work closely with all site departments reliant on validation support to facilitate validation aspects of all projects.
* Advise and contribute to Process Flow and Risk Assessment activities.
* Draft Validation Plans, Protocols and Reports when required.
* Subject matter expert within Investigations, CAPA, Quality Events.
* Functional expert for Change Request Impact assessments when delegated or in absence of Validation Section Leader
* Report validation status to Validation Section Leader
* Be aware of updated regulatory guidance and modify site procedures accordingly to maintain compliance
* Contribute to the Validation Community of practice when required
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
* Ensure that the Site Validation Master Plan is maintained accurately and Validation Plans are implemented for all relevant aspects of Equipment, Process, Cleaning, Computer Systems, Facilities/Utilities and Analytical Method validation. Maintain and support the updating of Validation Schedules within a team based validation structure.
* Author or review and approve the development and implementation of Validation Master Plans, protocols, reports and standard operating procedures relevant to Validation.
* Technical input into all Validation Lifecycle activities as part of a cross functional team. Provide guidance and support to other internal site departments ensuring compliance with applicable regulatory requirements (MHRA, EU, FDA, U.S., Notified Body and international), International Standards, and quality/validation regulations and guidance documents.
* Schedule and coordinate the review of process and equipment validation and re-validation / periodic review in accordance with the established Company validation policy and associated procedures.
* Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements.
* Provide support to the global organisation, (e.g. participating in the Validation Community of Practice) as appropriate, relating to validation activities and associated regulatory activities and procedures.
* Serve as subject matter expert and/or team member to support Quality Investigations, CAPA, customer complaint reports, audit findings, failure investigations and continuous improvement opportunities. Ensure accurate and timely resolution and closure to all issues.
* Contribute to and perform related training on site with regards to validation lifecycle and compliance.
* Prepare and present validation reports and Key Performance Indicators for management review. Review and monitor trends; initiate continuous improvement opportunities, communicate any matters outside the norm to the Validation Section Leader / Site Director of Quality.
* Support the IT department to ensure compliance with software and hardware validation regulatory requirements. Provide support in achieving / maintaining compliance with 21 CFR Part 11 / EU GMP Annex 11 and other guidance documents as appropriate to business needs.
* Comply with all statutory and Company requirements for health and safety.
* The above list is not exhaustive and the job holder may be expected to perform other reasonable tasks within the boundaries of their skills, in the interest of the job and the Company's performance.
Skills and knowledge
* Bachelors / Undergraduate Degree in a science or engineering related discipline (chemistry, biology, process engineering, pharmaceutical or medical technology preferred). Alternatively, in house or external training in Validation, Quality and Regulatory activities.
* Previous Validation experience in Healthcare/Pharmaceutical manufacturing/packing, medical device or biologics industry.
* Previous team leadership experience (direct or indirect) desirable, operating in a matrix organization.
* Demonstrated expertise in cGMP's, EU/FDA regulations, GAMP guidelines, assessment of risk and drafting of plans, protocols, reports and procedures
* Demonstrated understanding of Quality Assurance, Quality Control and Validation Risk Based Principles
* Demonstrated computer skills and a working knowledge of basic computer software (Microsoft Office, Excel, Visio etc. preferred)
* Demonstrated verbal and written communication skills, including the ability to conduct oral presentations
* Demonstrated success working within a team environment
* Ability to travel by car and/or plane, typically up to 5%. Additional travel may be required based on business need.
Acorn Recruitment Ltd is acting as an Employment Business in relation to this vacancy