Location
Hengoed, Caerphilly | United Kingdom
Job description
ABOUT THE JOB
Want a 3D Career? Join Norgine.
At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.
We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.
Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.
In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.
Because at Norgine, we transform lives with innovative healthcare solutions.
We have an exciting opportunity for a Validation Specialist to join Norgine.The person holding this position will report to Validation Section Leader and be a member of the Quality team.
The core responsibility of the of Validation Specialist is to enhance the 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.
If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
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 Norgine global organisation, 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.
- Maintain all validation compliance activities in a timely manner in line with the Site Validation Plan.
- 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.
Requirements
- 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.
Benefits
Benefits vary between locations.
Sound good? Find out more about the career you’ll have with Norgine, then apply here.
Anti-discrimination and equal opportunities:
- Norgine prides itself on its integrity, honesty and fairness in all aspects of our business. We aim to create a safe, welcoming and engaging workplace.
- Norgine provides equal opportunities to all employees and is strongly committed to the principle of equality regardless of race, religion or belief, age, nationality, sex, disability, pregnancy/maternity, gender reassignment, marital or civil partnership status, or sexual orientation.
- Norgine does not condone any discriminatory acts or attitudes in the conduct of our business between our employees or with external parties. This includes unlawful harassment and victimisation.
Job tags
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