|Job Title:||QA Officer|
|Salary:||£25000 - £35000 per annum|
|Contact Name:||Rachel Radford|
|Job Published:||March 01, 2017 10:51|
Your functions within the role will be:
- Responsible for reviewing and querying batch manufacturing, batch packaging and batch testing records against the registered specifications.
- Assist responsible person for initiating, reviewing and approving change controls and deviations / CAPAs and OOS/OOTs.
- Preparing release / rejection checklists for the QPs confirming conformance (or not) of the product batches.
- Assist in liaising with the European QA functions, RP the manufacturing sites and third party suppliers to secure the necessary documentation to the required level of quality.
- Monitoring product-specific trends in critical parameters.
- Coordination with Manufacturing, Logistics, Supply Chain and Distribution, through the Manager, Finished Products Releases, for the prioritization of batch review and batch release.
- Representing the QPs and QA Managers' concerns, following them up and relieving them of pressure relating with communicating and sharing information with the manufacturing, testing and release sites.
- Updating BMS excel sheet to provide visibility to all who are involved with batch release status of batches and to be used to inform if there are any issues with batches.
- Assist in Generating batch release KPIs.
- Assist in any other activities related to batch release.
- Possible requirement to act as back up for the Assistant QA Manager (FP Release).
- Reviewing batch records (manufacturing, packaging and testing) and completion of the batch review checklists
- Communication with manufacturing, importation warehouses, packaging sites and laboratories to follow-up on and obtain requested information
- Review of temperature and humidity data logged during transportation, highlighting any deviations for the QP's attention and review.
- Liaison with Regulatory Compliance function to ensure that all Batch Approvals Packages, Annual Product Quality Reviews, Product Stability and Product Trending is kept up to date.
- Communicating with the Supply Chain function through the Manager, Finished Product Releases, to ensure that releases are performed in advance of the market requirements.
- Training on QMS, training new reviewers
- Ad-hoc QA projects related to pipeline efficiency and QP support, upgrading / streamlining of the review system. as assistant to Manager, Finished Product Releases
- Chemistry, Biology, Biochemistry or Pharmacy degree preferably supported by certificate or diploma in pharmaceutics
- 2-5 years' experience in pharmaceutical manufacturing/quality environment with knowledge of GMP production or QC experience.
- Basic or intermediate knowledge of EU cGMP and other applicable regulatory requirements
- Hands-on experience working in a manufacturing site or QC laboratory.
- Documentation control and review experience (not essential)
- Analytical thinking, able to identify root cause, investigate problems and clearly identify solutions and way forward
- Excellent written and spoken English and a working knowledge of at least one other European or Indian language
- Basic knowledge of pharmaceutical manufacturing and packaging processes
- Ability to interpret documents and ask probing questions to obtain the necessary supporting information quickly
- Excellent team-working and managerial skills
- Thorough with an excellent eye for detail and good organizational skills
- Ideally has completed part or all of the EU QP training requirements
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