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Senior QA Specialist

Employer
i-Pharm Consulting
Location
Republic of Ireland, Dublin
Salary
EUR55 - EUR58.50 per hour
Start date
18 Jan 2023
Closing date
1 Feb 2023

View more

Discipline
Quality
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
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Job Details

Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
* Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities:
o DS, URS & QRAES documents
o Validation Plans, Protocols, IQ, OQ, PQ and associated documents
o Executed validation documents and reports
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet regulatory expectations.
* Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
* Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
* Quality review/approval of BOMs, MBRs and recipes.
* Write, review and approve Standard Operating Procedures
* Perform all activities in compliance with safety standards and SOPs
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

Preferred Qualifications

* University degree. Science or Engineering related discipline preferred.
* Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/ technology transfer / product lifecycle changes.
* Understanding of principles of Validation and New Product Introduction
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
* 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.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Find Us
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
GB
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