GMP Document Coordinator

2 months ago

Permanent role
Juniper Pharma Services, part of Juniper Pharmaceuticals is a successful contract development and manufacturing organisation based in Nottingham (NG8). With over 140 employees in the UK, we specialise in formulation development, analytical services and clinical manufacturing for pharmaceutical clients globally.

This is an exciting time for our rapidly growing business and we are looking for a new member to join the team.

The role:
Working within the Clinical Manufacturing function the role will involve:
• The preparation of, co-ordination and implementation of documentation activities required for process optimisation and clinical manufacturing activities to a high standard of quality in accordance with current Good Manufacturing Practice (cGMP) across a full range of dosage forms.
• Liaising directly with Programme Technical Leads, Study Directors and clients to ensure optimised transfer of critical technical information to ensure smooth and seamless transition of manufacturing processes from Formulation Development to GMP manufacturing.
• Working closely with the Formulation Development, Quality, Analytical and Project Management teams to ensure Master Batch Manufacturing Records, Quality Risk Assessments, Cleaning Technical Assessments, and training packs are in place prior to onset of GMP Manufacturing activities.
• Training the manufacturing team in study specific batch record completion.
• Ensuring that the recording of tasks and events on the batch manufacturing documentation is carried out both timely and accurately in accordance with GMP.

The ideal candidate will have:
• A minimum of 3-5 years of experience in a GMP pharmaceutical manufacturing facility.
• Direct responsibility for GMP Documentation production, execution and compliance.
• Excellent organizational, interpersonal and communication skills (written and verbal) are required in a client facing environment.
• Enthusiastic and passionate about pharmaceutical manufacture
• Ability to perform to a high standard in a fast-paced and highly regulated GMP Manufacturing environment
• Have an extremely high attention to detail
• Excellent numerical skills

Reward
• Competitive salary
• Discretionary annual bonus
• Contributory Pension scheme
• 25 days holiday – plus bank holidays
• Death in service
• Healthcare provision
• Free parking
• Childcare vouchers
• Perkbox
• Health Shield
• Learning & Development opportunities

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