Quality Technical Assessor - NPI
- Employer
- Hyper Recruitment Solutions
- Location
- Cambridge
- Salary
- £43000 to £46000 per annum
- Closing date
- 31 Jul 2019
View more
- Sector
- Pharmaceutical, Quality Assurance
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Technical Assessor - NPI will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for ensuring new product introduction is carried out in accordance within current regulatory guidelines and all relevant marketing/manufacturing authorisations. You will require a strong understanding of external quality compliance/supply chain assurance, and be required to support with technical and method transfer projects relating to NPI projects.
2. You will act as the Quality representative during the due diligence process in multiple projects following the identification of new business opportunities including product acquisitions and licence and distribution deals. The Quality Technical Assessor - NPI will be accountable for the Quality decisions and actions on projects that they represent.
3. The Quality Technical Assessor - NPI will maintain excellent knowledge of relevant regulatory guidelines as well as knowledge of Quality Requirements for all product platforms across different business areas (R&D, In licensed and New Acquisitions).
4. As the Quality Technical Assessor - NPI you will be responsible for liaising with third parties and internal departments to ensure that the risk is properly assessed during the due diligence process, you will provide technical expertise to multiple projects as they enter full scale manufacturing.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Quality Technical Assessor - NPI we are looking to identify the following on your profile and past history:
1. A strong understanding of current GMDP guidelines (EU,FDA,WHO,ICH,PIC/S), a GMDP auditor accreditation would be advantageous.
2. Proven industry experience in a range of manufacturing processes working in GXP compliant industries, with experience dealing with Third Parties.
3. A working knowledge and practical experience with CTD/Regulatory requirements along with Tech/Method transfer experience would be advantageous.
Key Words: GXP | GMP | QA | Quality | Compliance | Quality Assurance | CMO | Service Provider | Supplier | Audit | Internal | External | GDP | GCP | GLP | Pharmaceuticals | Solid Dose | Semi-Solid Dose | Validation | Tech Transfer | QMS | ICHQ10| MHRA | FDA | Eudralex | Bio-Pharmaceutical | Audit Plan | Auditor | QA Manager | QA Officer | QA Specialist | Senior QA Officer | International | Commercial | Analytical Testing | QC | External Quality | Third Party Compliance | Supplier | GMDP | GXP | API | External QA Lead | Third Party Manager | Supplier Quality | QA Manager | QA Lead | Principal Auditor | Regulatory | Method Transfer | Tech Transfer | CTD | Biologics | EU | FDA | PIC/S | WHO | ICH | NPI | Due Diligence | Product Acquisitions | Licensing | Compliance
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves
Company
Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.
Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.
Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.
We provide services across a broad range of industries including the following specialist sectors:
• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science
With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:
• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments
HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.
Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com
Or any of the social media routes below:
Twitter
Facebook
Linked in
Google +
- Website
- http://www.hyperec.com/
- Telephone
- 0203 910 2980
- Location
-
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB
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