Associate Batch Release Officer - Cambridge, United Kingdom - Mundipharma

Mundipharma
Mundipharma
Verified Company
Cambridge, United Kingdom

1 week ago

Tom O´Connor

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Tom O´Connor

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Description

Carrying-out the review, collation and approval of both in-house and contract Manufacturing, Quality Control, Filling and Packaging batch records in preparation for the Qualified Person certification, as well as performing inspection and approval of primary and secondary packaging materials, in support of Bard Operations to ensure timely supply of quality products to customers.

Key Responsibilities

Carrying-out the review, collation and approval of both in-house and contract Manufacturing, Quality Control, Filling and Packaging batch records in preparation for the Qualified Person certification;
- ensuring all records are complete and endorsed by appropriate personnel and all required in-process controls and checks have been made;
- confirming the impact of any change to product manufacturing or testing has been evaluated and any additional checks and tests are complete;
- confirming that all investigations pertaining to the batch being certified (including out of specification and out of trend investigations) have been completed to a sufficient level to support certification;
- ensuring for new products documented confirmation of compliance to Annex 16 requirements, including in relation to supply chain control, licensing, distribution and transportation arrangements.

Performing inspection and approval of primary and secondary packaging materials:

  • following established sampling plans and inspection criteria, liaising with the Warehouse, Planning department and packaging suppliers in case of any queries;
- liaising with Supplier Quality Assurance in case of defects identified during packaging inspection and raising complaints with packaging suppliers as required;
- completing packaging item approval in the ERP system upon confirmation of compliance and liaising with the Warehouse and/or Production to authorise use of packaging materials.

Contributing to ensure compliance is maintained in all aspects of QA Batch Release processes in support of the company's inspection readiness and compliance programs by:

  • delivering on-time personal Quality System commitments (including Change Control actions, CAPA, training, document periodic reviews);
- supporting internal and external audits ensuring all relevant documentation is 'inspection ready' and timely available.

Supporting the business in managing the risk to quality by:

  • proactively identifying and supporting the implementation of continuous improvement opportunities in QA and Bard Operations;
- timely communication of significant GMP and/or product quality issues to QA and Bard Operations management.

Education

  • Scientific degree in Pharmacy, Chemistry, Biology, Engineering or similar, or aligned working experience (preferred)
Experience

  • Solid practical experience (+2 years) in QA roles within the Pharmaceutical and/or Medical Devices Industry (preferred)
Knowledge and Skills

  • General understanding of GMP and Pharmaceutical regulatory requirements and of the regulatory framework for pharmaceuticals i.e. MIA, GMP cert, MA, types of regulatory variations;
  • Knowledge and experience of various manufacturing process and equipment for various dosage forms;
Communication & Working Relationships

Internal / External


Bard Operations (internal):

  • Liaises with Production, Quality Control and others operational departments to resolve queries related to batch records and other documentation;
  • Proactively escalates significant issues that require attention and/or additional support from other stakeholders.

Bard Qualified Persons (internal):

  • Proactively escalates significant issues that require attention or consultation with Bard Qualified Persons

Line Manager (QA Manager) and Team (internal):

  • Proactively escalates significant issues that require attention and/or additional support from other stakeholders;
  • Supports line manager in achieving performance goals and objectives.

Regulatory Agencies (MHRA, etc.) (external):

  • Communicates with MHRA and other competent authorities during inspections if required.
Working Conditions

  • Typical office environment
  • Infrequent product contact
  • Occasional travel

Additional Job Description:
12 month fixed term contract


Department:
Quality Assurance


Primary Location:
GB Cambridge


Job Posting Date:

Job Type:

Fixed Term Contract (Fixed Term)
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