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Senior QA Technical Support Specialist (Mainly Remote)

Employer
i-Pharm Consulting
Location
Republic of Ireland, Dublin
Salary
EUR60 - EUR65 per hour + Holiday Allowance
Start date
20 Sep 2022
Closing date
28 Sep 2022

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

Job Details

The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.


Key Responsibilities


* Accountable for Quality oversight of processes and procedures related to IS, Computerised Systems & Automation compliance (ex: BMS, PCS, MES, HMI upgrades etc..)
* Quality review and approval of CSV documentation
o Review of Risk Assessments, URS & QRAES documents
o Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
o Review of executed validation documents and reports
* Perform all activities in compliance with safety standards and SOPs
* Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
* 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.
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 (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as new MES or BMS system.
* 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.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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