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Smart4 Sciences - QA Manager/RP/RPi - London - hybrid positionSmart4 Sciences are currently partnered with a Global Biopharmaceutical... Read more

Smart4 Sciences - QA Manager/RP/RPi - London - hybrid positionSmart4 Sciences are currently partnered with a Global Biopharmaceutical company looking to recruit a QA Manager/RP/RPi to join their team on a hybrid basis at their UK Head Office in London.As a QA Manager/RP/RPi you will responsible for the upkeep of the QDA wholesale licence for the company, working closely with CMOs across the EU on supplier quality incidents and releasing finished product in line with RP/RPi requirements.Key Requirements.RPi certification with experience operating on and managing a WDA LicenceA strong background in all aspects of GMP/GDP Quality Assurance within the Pharmaceutical/Biopharmaceutical industryA strong background in supplier quality, managing CMOs, audits, inspections etcIf this role sounds of interest please apply today or contact Gareth Gooley at Smart4 Sciences for more information Read less

Smart4Sciences are currently working with a Pharmaceutical Company in the north of England to recruit a Qualified Person... Read more

Smart4Sciences are currently working with a Pharmaceutical Company in the north of England to recruit a Qualified Person responsible for sign off and release of finished Pharmaceutical productsAs a QP you will be responsible for reviewing and evaluating batch records and performing batch certification and release of solid-dose products in accordance with GMP and the Human Medicines Regulations. Key ResponsibilitiesPerforming QP batch certification of licensed medicines (per applicable regulations) and providing QP support as required for Quality issues.To act as 'Qualified Person' in approving Finished Product for release onto the marketplace.Verify and ensure that the products are manufactured, packed and tested to the requirements of registered MA.Responsible as named QP on the site MIA. To coordinate the preparation and hosting of MHRA and customer inspections.Key RequirementsEligible to act as Qualified person in UK. Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms.Extensive Pharmaceutical Industry with hands on experience in development/quality in a GxP environment. Knowledge and understanding of drug development process and the Global Regulatory Requirements and regulations related to GxP.Excellent working knowledge of EU GMPs, especially in the interpretation of requirements and guidance for the development, manufacture, control, and distribution of commercial product.This Qualified Person vacancy is an urgent requirement with interviews happening now - if you would be interested please apply today Read less

Formulation/Development Lead - Pharmaceuticals - North London Smart4Sciences are currently recruiting for a Formulation/Development Lead who will be... Read more

Formulation/Development Lead - Pharmaceuticals - North London Smart4Sciences are currently recruiting for a Formulation/Development Lead who will be responsible for working with one of North London's leading CDMOs of pharmaceutical products and lead all NPI and Tech Transfer activity.This Formulation/Development Lead position is a brand new role that has been created due to increased business and is a brilliant opportunity for a Scientist with a strong background in Formulation/Process Development to take a leading role in future projects within the companyKey responsibilitiesLead all Formulation/Development activities, working with clients and customers from the outset to interpret requirements and ensure projects are delivered on time and in a cost effective manner.Formulate Lab batches and Scale-Up to commercial manufacturingTroubleshoot issues found in the Formulation and Scale-Up processesRequirementsBSc or equivalent in a relevant subject matter ( Chemistry, Pharmaceutical Science etc)A strong background in Pharmaceutical Formulation, ideally within a CDMO environment with solid, semi-solid and liquid dose productsStrong written and verbal communication skillsInterviews for this Formulation/Development Lead position are happening now so please apply today or contact Gareth Gooley@ Smart4Sciences for more info Read less

Smart4Sciences - Quality Director - PharmaceuticalsSmart4Sciences are currently working with a Pharmaceutical company in Bedfordshire to recruit an... Read more

Smart4Sciences - Quality Director - PharmaceuticalsSmart4Sciences are currently working with a Pharmaceutical company in Bedfordshire to recruit an experienced Quality Director to lead and the develop an experienced Quality team and ensure all products are manufactured inline with GMP and MHRA Regulations.As the Quality Director you will be part of the SLT; essential in driving the business forward, developing current processes and delivering continuous improvement throughout the Quality function.Key ResponsibilitiesVerify and ensure that all processes and procedures to include effective data management systems, policies, processes and programmes to provide assurances of ongoing statutory, regulatory and MA compliance.As a key member of the SLT escalate any quality issues that are detected during batch review.Host MHRA inspections, writing the responses and liaising with the MHRA Inspectorate.Provide effective oversight of all remediation projects from a quality perspective.Responsible for the review and closure of Deviations, OOS, CAPA and Change controlKey RequirementsBSc or above in a suitable Scientific/Pharmaceutical DisciplineSignificant experience in a Quality Management/Leadership position within the Pharmaceutical IndustryIn-depth working knowledge of EU GMP guidelines and other regulatory requirementAbility to act as a Qualified Person is desirable but not essential.This Quality Director position is an immediate need to please apply now or contact Gareth Gooley at Smart4Sciences for more information Read less

Role: Stability AnalystLocation: DerbyshireSalary: £27,000 - £32,000Monday - Friday 8:30am - 4pmThe role: Focused on HPLC Analysis for... Read more

Role: Stability AnalystLocation: DerbyshireSalary: £27,000 - £32,000Monday - Friday 8:30am - 4pmThe role: Focused on HPLC Analysis for stability studies and validation of analytical methods. We're looking for degree qualified candidates that are experienced in the following:HPLC AnalysisStability studiesMethod developmentICH ValidationExperience in GMP environmentStrong Analytical SkillsResponsibilities Conducting stability studies on raw materialsAnalysing stability dataEnsure compliance with relevant regulatory guidelinesSupport process validation activitiesPreparing stability protocolsMaintaining stability chambersIf you want to apply or require further information please contact Jack Challinor at Read less

Smart4Sciences - Head of Quality - PharmaceuticalsSmart4Sciences are currently working with a Pharmaceutical Manufacturing company in Hertfordshire to... Read more

Smart4Sciences - Head of Quality - PharmaceuticalsSmart4Sciences are currently working with a Pharmaceutical Manufacturing company in Hertfordshire to recruit an experienced Head of Quality to lead and the develop an experienced Quality team and ensure all products are manufactured inline with GMP and MHRA Regulations.As the Head of Quality you will be part of the SLT; essential in driving the business forward, developing current processes and delivering continuous improvement throughout the Quality function.Key ResponsibilitiesVerify and ensure that all processes and procedures to include effective data management systems, policies, processes and programmes to provide assurances of ongoing statutory, regulatory and MA compliance.As a key member of the SLT escalate any quality issues that are detected during batch review.Host MHRA inspections, writing the responses and liaising with the MHRA Inspectorate.Provide effective oversight of all remediation projects from a quality perspective.Responsible for the review and closure of Deviations, OOS, CAPA and Change controlKey RequirementsBSc or above in a suitable Scientific/Pharmaceutical DisciplineSignificant experience in a Quality Management/Leadership position within the Pharmaceutical IndustryIn-depth working knowledge of EU GMP guidelines and other regulatory requirementAbility to act as a Qualified Person is desirable but not essential.This Head of Quality position is an immediate need to please apply now or contact Gareth Gooley at Smart4Sciences for more information Read less

Smart4 Sciences are currently working with a GMP regulated Pharmaceutical Manufacturer to recruit a Validation Officer to their... Read more

Smart4 Sciences are currently working with a GMP regulated Pharmaceutical Manufacturer to recruit a Validation Officer to their site in HertfordshireAs a Validation Officer you be part of a small team responsible for maintaining the site Validation Master Plan and will be required to lead, author and perform IQ, OQ, PQ protocols including Process, Cleaning, Equipment and Computer Systems; completing all associated documentation in accordance with ICH guidelines and GMP standards.Key ResponsibilitiesLead, author and execute IQ, OQ, PQ protocols on specific projects including Process Validation, Cleaning Validation, Computer System Validation and Facilities ValidationManage all validation documentation including commissioning test scripts, qualification/validation protocols, summary reports and risk assessmentsPerform qualification reviews, identifying and implementing any remedial work required.Key RequirementsBSc or equivalent in a relevant life science or engineering disciplineDemonstrable experience of validation and qualification within the Life Science sector including working knowledge of GMP requirements for validation in the UK and/or EU.Strong communication and project management skills including the ability to collaborate with colleagues at all levels.If you have prior experience in Validation and would be interested this position please apply to day or contact Gareth at Smart4 Sciences for more information Read less

Role: Senior QC AnalystSalary: Circa £35,000 (Negotiable)Monday - FridayLocation: Chester areaThe role: Carry out Analytical testing using a... Read more

Role: Senior QC AnalystSalary: Circa £35,000 (Negotiable)Monday - FridayLocation: Chester areaThe role: Carry out Analytical testing using a range of techniques such as UV, HPLC and GCCoaching/Mentoring junior members of the teamSupport management with timetabling analytical dutiesReporting any issues into Management The candidate: Degree in scientific disciplineUnderstanding and previous experience of working in a GMP EnvironmentExperienced in analytical techniques such as HPLC, GC, EVThe ability to lead a team If you would like to apply for this position or require further information, please email a copy of your CV to Jack Challinor on Read less

Smart4Sciences are currently working with a Pharmaceutical Company in the north of England to recruit a Qualified Person... Read more

Smart4Sciences are currently working with a Pharmaceutical Company in the north of England to recruit a Qualified Person responsible for sign off and release of finished Pharmaceutical productsAs a QP you will be responsible for reviewing and evaluating batch records and performing batch certification and release of solid-dose products in accordance with GMP and the Human Medicines Regulations. Key ResponsibilitiesPerforming QP batch certification of licensed medicines (per applicable regulations) and providing QP support as required for Quality issues.To act as 'Qualified Person' in approving Finished Product for release onto the marketplace.Verify and ensure that the products are manufactured, packed and tested to the requirements of registered MA.Responsible as named QP on the site MIA. To coordinate the preparation and hosting of MHRA and customer inspections.Key RequirementsEligible to act as Qualified person in UK. Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms.Extensive Pharmaceutical Industry with hands on experience in development/quality in a GxP environment. Knowledge and understanding of drug development process and the Global Regulatory Requirements and regulations related to GxP.Excellent working knowledge of EU GMPs, especially in the interpretation of requirements and guidance for the development, manufacture, control, and distribution of commercial product.This Qualified Person vacancy is an urgent requirement with interviews happening now - if you would be interested please apply today Read less

Formulation/Development Lead - Pharmaceuticals - North London Smart4Sciences are currently recruiting for a Formulation/Development Lead who will be... Read more

Formulation/Development Lead - Pharmaceuticals - North London Smart4Sciences are currently recruiting for a Formulation/Development Lead who will be responsible for working with one of North London's leading CDMOs of pharmaceutical products and lead all NPI and Tech Transfer activity.This Formulation/Development Lead position is a brand new role that has been created due to increased business and is a brilliant opportunity for a Scientist with a strong background in Formulation/Process Development to take a leading role in future projects within the companyKey responsibilitiesLead all Formulation/Development activities, working with clients and customers from the outset to interpret requirements and ensure projects are delivered on time and in a cost effective manner.Formulate Lab batches and Scale-Up to commercial manufacturingTroubleshoot issues found in the Formulation and Scale-Up processesRequirementsBSc or equivalent in a relevant subject matter ( Chemistry, Pharmaceutical Science etc)A strong background in Pharmaceutical Formulation, ideally within a CDMO environment with solid, semi-solid and liquid dose productsStrong written and verbal communication skillsInterviews for this Formulation/Development Lead position are happening now so please apply today or contact Gareth Gooley@ Smart4Sciences for more info Read less