Label Production Controller
7 months ago
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
- General Purpose of Role_: Execute Master Label requests, Master Label Amendment requests and Label Print requests.
- Main Responsibilities_:
- To liaise with the project managers to understand the clients labelling requirements and to gain approval of label masters.- To prepare English text for translation purposes ensuring text complies with Annex 13 requirements.- To liaise with label suppliers to obtain quotes and technical drawings.- To prepare purchase orders for ordering labels.- To design and produce single layer master labels, leaflets or code breakers from approved text using Prisym software.- To design label proofs using Indesign software to be sent to suppliers for preparation of labels that cannot be printed in-house eg. specialist labels, multi-language booklet labels, and folded leaflets.- To design and produce master labels for booklet labels that require over-printing using Prisym software.- To create or import randomisation code lists using Prisym software.- To ensure all blank or pre-printed labels, leaflets and code breakers for clinical trial use are stored and identified correctly.- To print and issue labels or leaflets according to requirements in the labelling and packaging works orders or print requests.- To amend label masters when necessary by client requests.- Support project and label design specific queries.- To aid with the development and implementation of Standard Operating Procedures and Standard Operating Instructions for label production and control.- Maintain Label stock on ERP system.- Maintain the cleanliness of the Labelling room.- Comply with the company's Health and Safety standards.- Where required, undertake tasks and projects outside the job holder’s area of responsibility.
- Outcomes of Role_:
- Label designs are planned and prioritized as per labelling requests.- Correct labels are produced in compliance with cGMP, regulation and in line with clients’ instructions.- All labelling operations are completed to the appropriate company standards.- All labelling equipment is maintained to the appropriate standard.
- Behaviours_:
- Team player with a flexible approach.- Operates in cool manner.- Analytical thinking and Problem Solving.- Judgement and decision making.- Self-motivated.- Takes initiative.- Trustworthiness.- Conscientiousness.- Customer Service.- Attitude embracing company vision and values.
Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
- PCI Pharma Services is an Equal _Opportunity/Affirmative_ Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
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