Senior QA Specialist (Packaging)
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2323 |
| Job Views | 232 |
- Description
- We have an exciting opportunity available for a Senior Quality Assurance Specialist (Packaging), with our client who are a leading biopharmaceutical company. This position is a senior and active role within the broader QA function.
You will report to a QA Senior Manager and will be required to be a Subject Matter Expert in your assigned area of responsibility. QA specialists will be required to understand and grasp a broad range of quality related competencies.
In addition to routine Quality Assurance duties, QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
Why you should apply:
Join a progressive company with state of the art working facilities, which include an onsite gym and flexible working conditions such as flex hours and WFH
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
What you will be doing:
Provide overall quality direction and oversight for Packaging area, which will include associated support functions: Process Development, Validation, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and Company expectations.
Provides real-time QA oversight and support for Production Operations and Plant QA Senior Associates in the Packaging Hall, by providing Purposeful Quality presence on the floor.
Support and represent Quality during audits and inspections
Collaborates with Operations to resolve quality and compliance issues, including but not limited to Change Controls, Deviations and CAPAs. Ensuring the scope of Quality records are clear and the implementation corrective and preventative measures are robust and timely.
Support a safe working environment by complying with all pertinent environmental health/safety practice rules and regulations
Supports Lean Transformation and Operational Excellence initiatives
Write, review and approve Standard Operating Procedures in accordance with Company Policies.
Perform all activities in compliance with Company safety standards and SOPs
What you need to apply:
Relevant experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems)
Experience working with combination products or devices in packaging-related or complaint-handling activities
Experience in change control, non-conformance, corrective and preventative actions.
Ability to operate across functional boundaries, both internal and external.
Ability to work independently and remotely with minimum direct supervision.
Critical thinking skills.
Strong organisational, communication, coordination, and meeting facilitation skills.
Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
