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 in Hengoed, South Wales.
The core responsibility of the Validation Specialist is to enhance validation practice and compliance, support improvement to the validation system and 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.
KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
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, (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. MAIN TASKS
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. RELATIONSHIPS:
Maintains excellent working relationships with all departments across Hengoed site. Liaise with other manufacturing sites within Norgine and through the External Network Structure. 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 (minimum 5 - 10 years) 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
Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information. Sound good? Find out more about the career you'll have with Norgine, then apply here. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries
Non-profit Organizations and Primary and Secondary Education
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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, (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. MAIN TASKS
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. RELATIONSHIPS:
Maintains excellent working relationships with all departments across Hengoed site. Liaise with other manufacturing sites within Norgine and through the External Network Structure. 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 (minimum 5 - 10 years) 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
Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information. Sound good? Find out more about the career you'll have with Norgine, then apply here. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries
Non-profit Organizations and Primary and Secondary Education
#J-18808-Ljbffr
