Smart4Sciences - Qualified Person
Smart4Sciences are currently recruiting a Qualified Person to join a Pharmaceutical Company in South Yorkshire. As a QP you will be responsible for reviewing and evaluating batch records and performing batch certification and release of sterile products in accordance with GMP and the Human Medicines Regulations. 
Key Responsibilities

Act as QP for all products manufactured and packaged at the site; in accordance with marketing authorisations  and manufacturing licences
Provide QA Support to manufacturing, packaging and supply chain
Assure product, process and facilities comply with national and international regulatory requirements
Provide support for customer visits and audits while also conducting external audits of suppliers, vendors and service providers

Key Requirements

You must be a Certified Qualified Person
Experience releasing pharmaceutical products in accordance with Annex 16 GMP regulations and 
Leadership/line management experience is preferred
Experience with Sterile Pharmaceutical products is preferred

This Qualified Person vacancy is an urgent requirement with interviews happening now - if you would be interested please apply today

Microbiologist
I am currently working with the worlds most automated wet wipe manufacturers based in their Flintshire site in North Wales. You will be working on some of the market leading products, gaining some great experience and will be provided with some good training programmes to allow continuous career development.
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Key responsibilities for the Microbiologist
 

Perform Microbiology testing on the manufacturing facilities to ensure production is complaint.
Provide training sessions for others on testing methods.
Complete final sign off for Microbiology studies/ validation.
Ensure document archiving is complaint and accessible.
Environmental monitoring, waste disposal, water systems and other related tasks.
Perform equipment calibration, troubleshooting and validation for the laboratory.
Support with internal audits when required, for both training purposes and external audits.

Requirements for the Microbiologist

Hold a Scientific Degree.
2 Years’ experience working within Microbiology.
Strong written and verbal communication skills.

Benefits for the Microbiologist

Free on-site parking.
Fantastic career development opportunities.
Continuous company growth.
Social working hours- No weekends.
Early finish on a Friday.
 

To apply for the Microbiologist or here more information, please contact Liam Shannon at Smart4Sciences on 01925 909045.

Product Specialist – Northamptonshire - HybridA long standing family, community led business are looking for Product Specialist to join their small dynamic team. The role offers great learning and development opportunities as well as career progression. As a Product Specialist you will have the chance to manage projects, bring your ideas to the table and have a real influence on the business. This Product Specialist role is deal for an enthusiastic, process driven person with solid portfolio/product management experience!Requirements;Degree educated in business, marketing, Life Sciences, or a relaavent field.3 plus years product management experience; (medical device, healthcare, or professional goods industries would be preferable)Process driven, analytical and previous pricing experienceEnthusiastic with great communication skills able to work between multiple teams in the business such as R&D, NPD, regs and Supply chainPast experience of keeping on top of market trends keeping product portfolios up to dateThe roleThe Product Specialist joining the team will be focusing on the development and commercialisation of medical grade infection control productsThe role oversee the entire product lifecycle, ensuring company products meet rigorous industry standards, address customer needs, and driving company growth.This will includeProduct lifecycle ManagementSales enablementResource and asset managementProduct launchPerformance analysisReportingMarketing / customer insightsIf you have experience as product specialist, product manager, NPD, project manager, portfolio manager please send me your CV!

CQV Contractors  - North East (Site Based) 
4-6 Months 
100% Site based 
Experienced CQV Contractors who ideally live in the Teeside area or able to work away with 100% Monday-to-Friday onsite. 
Must have Pharmaceutical Commissioning, Qualification, Validation experience (CQV)
Specific Expertise in Clean Systems & Clean Utilities for the manufacture of complexed biologics. 
If you would like to discuss, please call Simon Fowler 
Contract Recruitment Specialist (Pharmaceuticals) 
Smart4Sciences 

Smart4Sciences are currently working with a Pharmaceutical company in the North East to recruit a QA Officer on a permanent contract
As a QA Officer you will be part of technical team responsible for the maintenance and ongoing improvement of the quality management system.
Key Responsibilities 

Ensuring compliance with the requirements of pharmaceutical GMP
Preparation and/or review of quality documentation including product quality reviews (PQRs), periodic safety update reports (PSURs), quality risk management, stability study protocols, etc.
Performing internal and external audits.
Documentation and investigation of out of specification investigations (OOSs), deviations and change controls.
Corrective and Preventative Action (CAPA) planning, implementation, and monitoring.

Key Requirements

Prior experience in Pharmaceutical GMP is essential.
Prior experience in Pharmaceutical Quality Assurance is highly desired.

This QA Officer position is an immediate need and is interviewing now so please apply today

Regulatory Affairs Officer (Hybrid working)
I currently have a great opportunity for a Regulatory Affairs Officer to progress or start their career within Parallel import. This position is open for both Regulatory and Quality Assurance professionals, so please if you are unsure, give me a call 01925 909045.
Key responsibilities for the Regulatory Affairs Officer (Hybrid working)
 

Ensure Regulatory compliance with drugs imported overseas.
Lead any changes within the regulations and ensure the QMS is complaint with these.
Review and monitor licence applications to the MHRA.
Manage Supplier and Vendor communication.
Ensure all labelling is to MHRA regulations.

Requirements for the Regulatory Affairs Officer (Hybrid working)
 

Hold a Scientific Degree.
1 years’ experience within Pharmaceutical or Medical Device Regulatory Affairs or 5 + years within Quality Assurance
Expert organisation skills
Strong written and verbal communication skills.

Benefits for the Regulatory Affairs Officer (Hybrid working)
 

Free on-site parking.
Hybrid working policy up to 4 days remote
No weekends.
25 Days holiday + bank holidays.

To apply for the Regulatory Affairs Officer (Hybrid working) or here more information, please contact Liam Shannon at Smart4Sciences on 01925 909045.

Quality Control Analyst
I am working with a leading generics manufacturer based in the Liverpool area looking for an experienced QC Analyst to join the team due to continuous growth.
Key responsibilities for the Quality Control Analyst

Perform routine analysis via HPLC.
Assist junior members of the QC team with analytical studies and development.
Routine testing on finished products.
Assist with continuous improvement and work with the QC Supervisor to implement this.
Write technical/scientific reports.
Assist with Method Transfer and Validation.

Requirements for the Quality Control Analyst

Hold a Scientific Degree.
2 Years’ experience working within Quality Control.
Strong written and verbal communication skills.

Benefits for the Quality Control Analyst

Free on-site parking.
No weekends.
25+ 8 bank holidays.

To apply for the Quality Control Analyst or here more information, please contact Liam Shannon at Smart4Sciences on 01925 909045.

Responsible Person
A key position has become available with one of the UKs leading generics manufacturers based in Liverpool. You will be responsible for the distribution of licenced drugs from the Warehouse in Liverpool.
Responsibilities for the Responsible Person

Acting and named as a Responsible Person.
To carry Pharmaceutical GDP duties surrounding EU guidelines.   
General operations within the Warehouse.
Amending & Creating a QMS to in line with your clients business model. 

Requirements for the Responsible Person

3 years of experience withing pharmaceutical wholesale distribution (QA)
Knowledge and understanding of the current requirements of GDP. 
Line management experience
Experience in the Export & Import of medical products

Benefits for the Responsible Person

Free parking
Social working hours
No weekend work
Good career development opportunities

Please contact Liam Shannon at Smart4Sciences on 01925 909045

Head of Production
I am currently recruiting for a Head of Production in Runcorn, this is a really exciting opportunity as you will be the 1st hire within Production. The company I am working with, specialise in inhalation and respiratory drugs, so a great chance to get involved with one of the niches within pharmaceuticals. This is an important role for the business and will be working with the Lead engineer to qualify the manufacturing and production equipment, there is no team at the moment, and you will bring your own team in!
 
Responsibilities for the Head of Production

Develop, execute and plan the  qualification of the production facility to pharmaceutical cGMP.
Lead and manage the production team and daily operations within the production facility, ensuring cGMP compliance.
Implementation of KPIs, SOPs and training programs for the Production Team.
Collaborate with different departments for the potential of new business development opportunities from the current resource.
Work closely with both QA and QC for any manufacturing issues and look to implement changes to improve this.
Training, development and recruitment of staff within the department.

Experience & Qualifications required for the Head of Production

10+ years of experience working within Pharmaceutical Production and 5 years being within a management position.
Experience within the inhalation industry, MDIs
Previous experience with setting up a new cGMP manufacturing facility
Experience with, budget, Supplier and Stake Holder management
Experience within bringing pharmaceutical drugs from development, to commercial manufacturing.
 

Benefits for the Head of Production

25 days holiday, plus bank holidays (increasing with service)
Discretionary Bonus
Cycle to Work Scheme
Free parking

Please contact Liam Shannon at Smart4Sciences on 01925 909045.

Quality Control Analyst
I am working with a  pharmaceutical manufacturing site based in Wrexham, with manufacturing of multiple dosage forms, this is a fantastic opportunity for someone looking to develop their skillset and career within pharmaceuticals. 
Key responsibilities for the Quality Control Analyst

Perform method transfer on analytical procedures with instruments such as HPLC.
Assist junior members of the QC team with analytical studies and development.
Routine testing on finished products.
Assist with continuous improvement and work with the QC Supervisor to implement this.
Write technical/scientific reports.
Leadership within the laboratory for the analyst within the team

Requirements for the Quality Control Analyst

Hold a Scientific Degree.
2 Years’ experience working within Quality Control.
Strong written and verbal communication skills.

Benefits for the Quality Control Analyst

Free on-site parking.
Subsidised canteen
Healthshield cash plan/counselling
No weekends.
25 days holiday + 8 bank holidays.

Please contact Liam Shannon at Smart4Sciences.