A Vacancy Exists for a Labelling Co-Ordinator reporting to the Labelling Supervisor Role
To carry out all daily duties required for the review and implementation of printed packaging in compliance with GMP, Quality Systems and Customer requirements of the company. Key responsibilities include:
Assistance with the PMCF process: Assistance to other area’s within the company for the initiation of Printed Material Changes.
Review of Printed Material: Review of printed material against FDA, EU, Canadian and ISO guidelines.
Printed Change and Effectivity date Meetings: Running of a printed change meeting for the review and approval of a printed change, where applicable. Running of an effectivity date meeting to review the changeover dates for printed packaging and ensure all documents/data are updated in a timely manner.
Proof reading: Review of printed material against requested changes documented within the approved PMCF.
Overprinted label templates: Setting up of overprinted label templates (as defined in the approved PMCF) on the applicable label printing software
Liaise for translations & checks: Liaise with approved vendor for quotation and timeline for translation. Liaise with nominated distributors for translation check.
Artwork/Print suppliers: Provide accurate changes to artwork suppliers & approvals to print suppliers.
Document & Data changes: Process Document & Data changes when relating to printed materials changes.
Packaging specifications: Assistance with the review of packaging specifications, where necessary.
Other Duties: Providing assistance to the Documentation & Data area, if required. To carry out other duties, as requested by the department supervisors/manager.
To comply with Company Policies & Procedures at all times.
Attention to detail will also be a necessary attribute of the successful candidate
Continuous improvements: Providing continuous improvements ideas to processes/procedures.
Minimum Qualifications/Experience
Qualification in/experience in Quality Control/Reg Affairs within a healthcare industry (and/or) a degree/diploma in the related field.
A good working knowledge of the regulatory requirements related to labelling.
Understanding of quality control and cGMP/GLP requirements.
Good working knowledge of Microsoft software.
Previous experience in Artwork origination, knowledge of print software / zebra printers or knowledge of Macola or similar data systems an advantage.
Skills and Behaviours: o The successful applicant will be a self starter and have excellent communication skills (both written and verbal). o Will be focused on achieving results through team and individual development. o Will have proven ability in both personal decision making and empowering others to make decisions.
Will require demonstrated attention to detail, work with a sense of urgency and have the ability to be impartial and objective.
Will have excellent organisation, planning and judgement skills and will be able to positively achieve results through others.
o Ability to initiate change and improvements as per the regulatory requirements. o To show a high level of care and attention to all aspects of the role and show a desire to achieve excellence through the own initiative. o Ability to lead and drive self managed projects. o To be flexible and willing to fulfil tasks to completeness. Language Skills:
Ability to read, analyze, and interpret technical data, technical procedures, or governmental regulations. Ability to prepare Power point presentations. Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
Wicklow Recruitment Ltd. 58 Main Street, Wicklow Town, Co. Wicklow.
Wicklow Recruitment Ltd.