Job Description

QA Supervisor \xe2\x80\x93 GMP / pharmaceuticals

Livingston - permanent role

If you are keen to enhance your experience and career within an exciting International Scientific organisation offering a superb working environment, superb benefits and careers, this could be the role for you!

The overall objective of this job role is to supervise, guide and manage the tasks and workloads of an expanding QA team. Your remit will be to effectively plan and track all activities for the team to maintain the compliance of manufacturing and all associated support activities, batch release and regulatory requirements for the site.

Your remit will be highly varied and will include \xe2\x80\x93

Provide direct line management to a team of Quality Assurance/Operations Specialists, review individuals\xe2\x80\x99 performance regularly to ensure development of individuals\xe2\x80\x99 skills/knowledge. Complete performance reviews as per site requirements.

Plan, organise and track team routine daily activities to ensure on time completion to meet site requirements.

These activities include but are not limited to:

\xc2\xb7 Batch record review,

\xc2\xb7 Co-ordination of activities to ensure effective operation of QMS

\xc2\xb7 Review and closure of Site QMS

\xc2\xb7 Review of new and updated documentation

\xc2\xb7 Batch release activities

\xc2\xb7 Temperature excursions

\xc2\xb7 Product technical complaints.

\xc2\xb7 Validation

\xc2\xb7 Internal/External Audits and In process inspections

\xc2\xb7 Plan, organise and track team routine daily activities to ensure all QA QMS is completed on time

\xc2\xb7 Take ownership for team specific processes as defined by the Head of QA.

\xc2\xb7 Plan and track activities to ensure delivery within required timelines and define, measure and report appropriate key quality metrics for these systems to the Head of QA to demonstrate compliance and show on going continuous improvement.

These specific systems/areas include but are not limited to:

\xc2\xb7 Supplier Assurance,

\xc2\xb7 Internal/External Audit Process,

\xc2\xb7 Deviations/Investigations,

\xc2\xb7 Data Integrity,

\xc2\xb7 Software projects/IT compliance,

\xc2\xb7 Batch Release,

\xc2\xb7 Change Control (SmartChange),

\xc2\xb7 Training (SmartTrain)

\xc2\xb7 Document Control (SmartDoc)

\xc2\xb7 Provide QA representation for site projects and plan and track to ensure QA team project actions are delivered to meet the project timelines

\xc2\xb7 Provide support for the delivery and presentation of key quality metrics for the site and QA department for presentation and discussion at the monthly meetings.

The successful candidate will be / will have -

\xc2\xb7 Educated to at least degree level in a relevant discipline (Biology, Chemistry, Pharmacy) or equivalent experience

\xc2\xb7 Experienced in EU and FDA cGMP / GDP regulatory requirements for Quality Systems, including Supplier Management and Internal/External Auditing

\xc2\xb7 Verifiable supervisory experience in Quality Assurance

\xc2\xb7 Experience working within a GMP / GDP manufacturing environment

\xc2\xb7 Proven track record of supervising teams

\xc2\xb7 Previous experience of working to tight deadlines and re-prioritising workload

\xc2\xb7 Proven experience of working with operational excellence improvement tools

\xc2\xb7 Experience of leading and delivering quality metrics

This is a superb opportunity to join a highly successful company in a highly varied role.

The role is on a permanent basis with an attractive salary and excellent benefits package including bonus and private health care & more.

On application please provide details regarding salary and re any applicable notice period and re sizes of teams managed.

BR Recruitment