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DPDBicester
Starting your own business as an Owner Driver with DPD has never been easier.With our Owner Driver Franchise scheme, you can run your own business and share in the growing success of DPD.We give you all you need to get started.From your own van, the best tech in the business and all the training to ...
DPDBicester
Starting your own business as an Owner Driver with DPD has never been easier.With our Owner Driver Franchise scheme, you can run your own business and share in the growing success of DPD.We give you all you need to get started.From your own van, the best tech in the business and all the training to ...
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Do you have inventory / stock admin experience within the Medical Device / Pharma industry?
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• Are you available at short notice, with own transport?
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Sr. Manager, Quality Control
Abingdon | careers-replimune.icims.com |
Overview:
The Sr. Manager, Quality Control has the responsibility of managing and overseeing work of direct reports, managing individuals or a team, leading method transfer and validation activities, stability study coordination, management of external testing, write and approve CoAs, assay control, reference material and sample management, writing, reviewing and approving various QC related documents as required.
This role also requires performing QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) as required, setting up and maintaining systems and processes for QC Laboratory, scheduling, review and approval of tests results, management of the QC laboratory and interactions with other groups.
This position is based in Milton Park, and has a 5 day on site expectation.
Responsibilities:
• Manage direct reports including their training, scheduling of work, coaching well as
leading them to achieve departmental goals and objectives
• Lead QC assay transfer/validation activities to introduce new assays into QC lab
within given time frame.
• Set-up GMP compliant QC processes and maintain them appropriately for audit
readiness.
• Review and approve QC test data and CoA (Certificate of Analysis)
• Write, review and QC approve change controls, CAPA, deviations, protocols,
reports forms and templates related to QC operations as applicable.
• Lead investigations for OOS (Out of Specification), OOT (Out of Trend) results in
timely manner.
• Participate in regulatory inspections and submissions.
• Oversee and manage maintenance of QC laboratory and equipment.
• Lead QC laboratory equipment introduction and participate in equipment
validation.
• Oversee sampling and storage of QC samples and maintain inventory.
• Coordinate shipping and receipt of QC samples and other QC related material.
• Training others within department on methods and processes in accordance with
GMP practices.
• Become SME for QC methods, monitor method performance and lead trouble
shooting/ method optimisations as required.
• Interact within internal as well as across other functional group to communicate
QC requirements.
• Deputize for other roles during periods of absence or when responsibilities have
been delegated.
• Perform QC testing following Standard Operating Procedures (SOPs).
• Review and complete documentation in accordance with current Good
Manufacturing Practices (cGMP)
Other responsibilities
• Troubleshoot equipment and analytical methods
• Manage technical studies performed with external companies
• Represent QC at inter-departmental meetings and interact with external vendors,
as necessary.
Qualifications:
Educational requirements:
• BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
• More than 5 years GLP / GMP experience in a relevant work environment.
Experience and skill requirement:
• 6 years or GLP / GMP experience in a relevant work environment.
• Prior line management experience preferred.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others and lead a team
• Effective communication skills
• Good organizational and time management
The Sr. Manager, Quality Control has the responsibility of managing and overseeing work of direct reports, managing individuals or a team, leading method transfer and validation activities, stability study coordination, management of external testing, write and approve CoAs, assay control, reference material and sample management, writing, reviewing and approving various QC related documents as required.
This role also requires performing QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) as required, setting up and maintaining systems and processes for QC Laboratory, scheduling, review and approval of tests results, management of the QC laboratory and interactions with other groups.
This position is based in Milton Park, and has a 5 day on site expectation.
Responsibilities:
• Manage direct reports including their training, scheduling of work, coaching well as
leading them to achieve departmental goals and objectives
• Lead QC assay transfer/validation activities to introduce new assays into QC lab
within given time frame.
• Set-up GMP compliant QC processes and maintain them appropriately for audit
readiness.
• Review and approve QC test data and CoA (Certificate of Analysis)
• Write, review and QC approve change controls, CAPA, deviations, protocols,
reports forms and templates related to QC operations as applicable.
• Lead investigations for OOS (Out of Specification), OOT (Out of Trend) results in
timely manner.
• Participate in regulatory inspections and submissions.
• Oversee and manage maintenance of QC laboratory and equipment.
• Lead QC laboratory equipment introduction and participate in equipment
validation.
• Oversee sampling and storage of QC samples and maintain inventory.
• Coordinate shipping and receipt of QC samples and other QC related material.
• Training others within department on methods and processes in accordance with
GMP practices.
• Become SME for QC methods, monitor method performance and lead trouble
shooting/ method optimisations as required.
• Interact within internal as well as across other functional group to communicate
QC requirements.
• Deputize for other roles during periods of absence or when responsibilities have
been delegated.
• Perform QC testing following Standard Operating Procedures (SOPs).
• Review and complete documentation in accordance with current Good
Manufacturing Practices (cGMP)
Other responsibilities
• Troubleshoot equipment and analytical methods
• Manage technical studies performed with external companies
• Represent QC at inter-departmental meetings and interact with external vendors,
as necessary.
Qualifications:
Educational requirements:
• BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
• More than 5 years GLP / GMP experience in a relevant work environment.
Experience and skill requirement:
• 6 years or GLP / GMP experience in a relevant work environment.
• Prior line management experience preferred.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others and lead a team
• Effective communication skills
• Good organizational and time management
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