Radiopharmacy Head of Production

• Ensure products are manufactured and stored in compliance and that all manufacturing activities are recorded and archived.
• Approve manufacturing instructions EU-GMP Ch. 4 and ensure their creation, periodic review, update and adherence.
• Control maintenance and qualification of rooms and equipment used in manufacturing EU-GMP Ch. 3.
• Ensure initial and periodic validation/re-validation of processes EU-GMP 5.21–5.24.
• Organise initial and continuous training of personnel EU-GMP 2.8–2.12.
• Verify manufacturing instructions against dossier, GMP and pharmaceutical rules and ensure compliance.
• Make sure only APIs and raw materials made under GMP and of proven quality are used.
• Prevent cross-contamination and mix-ups through technical and organisational measures.
• Sign and date batch records to confirm compliant manufacture, labelling and package leaflet.
• Ensure all deviations are documented and thoroughly investigated.
• Co-operate with competent authorities as far as manufacturing is concerned.
• Departmental planning and leadership tasks.
• Responsible for the management of an engaged and motivated team, effectively utilising internal resources and supports including induction, buddy system, performance management, delegation, career development, One-to-ones and training.
• Assist in developing and implementing standard operating procedures and training plans for the team.
• Recommend new processes to enhance operational effectiveness.
• Undertake tasks as directed by the site manager to ensure the project is delivered on time and on budget.
• Set clear objectives and fully train all new staff members and ensure all staff are trained in all aspects and duties required on site to ensure resilience during periods of staff leave.
• Record and maintain training competency checklist for new starters during training until all training is complete.
• Manage staff roster and annual leave/absence requests.
• Organise weekly and monthly staff meetings, compile minutes and agendas.

• Drafting, reviewing and approving SOPs and other GMP documents.
• Contributing to dossier maintenance, safety, environmental, validation, self-inspections, supplier oversight, recalls, etc.

• A recognized qualification/degree in natural sciences and at least one year of practical experience in nuclear medicine or radiopharmaceutical chemistry.
• A minimum of 5 years’ industry experience in the area of (radio)pharmaceutical production or manufacturing.
• Leadership/Management qualification desirable.
• An understanding of and track record of implementing effective clinical governance.
• Technically competent: high technical skill level.
• Excellent communication and people skills.
• Team leadership skills: to motivate and lead strong teams.

• Excellent attention to detail and customer service orientation.
• Excellent communication and leadership skills.
• Demonstrates initiative and highly motivated.
• Ability to work in a challenging environment with changing priorities.
• Flexibility and adaptability.
• Proven organisational skills.
• Evidence of teamwork/strong team player.

Alliance Medical