QA Officer
- North West
- Permanent
- Compliance / Quality Assurance
This vacancy has now expired
Our world-leading Pharmaceutical client based in the North West of the UK are looking for a QA Officer to specialise in one of three main areas within the organisation (Project Operations / Project Introduction / Project Lifecycle). This role will be an essential function within the Quality Assurance department. It will involve working closely with the Production, Laboratory, Product Development, Project Management and Business Development teams.
Project Operations Responsibilities:
- Performing quality assurance checks during manufacturing /packaging / labelling activities as defined in the batch document.
- Reviewing and approving executed batch manufacturing records to ensure products have been manufactured compliantly.
- Reviewing and approving environmental monitoring results for the GMP cleanrooms.
- Verifying that clean room conditions were achieved during manufacturing operations.
- Provide quality guidance during manufacturing issues, help to define batch record comments to explain events and assess the impact to the manufacturing process and the product quality.
- Providing Quality guidance and support in laboratory investigations, deviations, change controls, quality improvements, customer and supplier complaints, implementation of CAPA.
- Approving raw materials for use in clinical manufacture.
- Reviewing and approving Standard Operating Procedures.
Project Introduction Responsibilities:
- Reviewing and approving specifications for raw materials, IPCs, finished products, final packaging.
- Reviewing and approving SOPs, analytical methods, stability protocols, technical reports.
- Reviewing and approving method qualification / validation performed both internally and by external parties.
- Reviewing and approving executed Feasibility / Engineering batch documents, the associated analytical testing and resulting technical report (to facilitate the handover into clinical manufacture).
- Reviewing and approving master batch records (for dispensing, bulk manufacture, packing and labelling activities) and label templates.
- Approving raw materials for use in clinical manufacture.
- Providing Quality guidance and support in laboratory investigations, deviations, change controls, quality improvements, customer and supplier complaints, implementation of CAPA.
Project Lifecycle:
- Preparation & QA review of batch dossier and product specification files to support QP release of product to clinic.
- QA review of change controls including shelf life extensions for products in the clinic.
- Performing quality assurance of stability data to support shelf life of product in clinic.
- Providing Quality guidance and support in laboratory investigations, deviations, change controls, quality improvements, customer and supplier complaints, implementation of CAPA.
- QA review of updates to finished product specifications, IPC specifications, analytical methods, SOPs and stability protocols etc.
Key Skills / Background:
- Possess a scientific or pharmaceutical production background (degree in scientific or pharmaceutical science preferred)
- Strong understanding of Good Manufacturing Practice and its application for both Investigational Medicinal Products and Commercial Products
- Prior experience in Quality Assurance role.
- Experience of working closely with manufacturing is preferred.
- Good level of attention to detail, good organisation and interpersonal skills.
- Confidence and ability to represent the department in project meetings.
If you are interested in learning more, please apply today.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
To view Quanta's privacy policy, please visit our website
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
Save as job alert
Similar Jobs
Salary
Competitive
Location
Dublin
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Dublin
Description
QC Lab Systems Engineer - Life Science - Dublin - 12-Month Contract Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives?
Reference
32560
Expiry Date
01/01/0001
Author
James SmithsonAuthor
James SmithsonSalary
Competitive
Location
Cork
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Cork
Description
Quality Systems Specialist - Cork, Ireland - 11-Month Contract One of our global Pharmaceutical clients is looking for a Quality Systems Specialist to join their team close to the picturesque and
Reference
33962
Expiry Date
01/01/0001
Author
Jack SteadmanAuthor
Jack SteadmanSalary
Competitive
Location
Vlissingen
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
Rotterdam
Description
Civil QC Inspector - Energy - Rotterdam (South) - 12-Month Contract+ Are you a Civil QC Inspector looking for your next contract? We are working with a world leader in solutions for offshore
Reference
33246
Expiry Date
01/01/0001
Author
Brandon SalesAuthor
Brandon SalesInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Alex
I manage this role.