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Senior QA Specialist

Employer
i-Pharm Consulting
Location
Republic of Ireland, Dublin
Salary
£300 - £350 per day
Start date
19 Aug 2019
Closing date
2 Sep 2019

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Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Senior Quality Assurance Professional - QA Technical Support (QA TS)

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. QA TS Specialist will be required to understand and grasp a broad range of quality related competencies.
In addition to routine Quality Assurance duties, QA TS Specialist 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 products or functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control. QA TS Specialist may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.

QA TS Specialist Responsibilities: (may perform some or all of these duties)
* Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet Amgen and regulatory expectations.
* Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
* 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.
* Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
* Review and approval of Master Batch Records and SAP BOMS
* Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
* Perform all activities in compliance with Amgen 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

Basic Qualifications
* University degree. Engineering or Science related discipline preferred.
* Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry ideally, however candidates from clinical, med device would be consideration but they would need to have aptitude, self motivated with a QA or validation background
Experience working with dynamic cross-functional teams and proven abilities in problem solving and decision making
* Excellent written and verbal communication skills
* Strong organizational skills, including ability to follow assignments through to completion

Preferred Qualifications
* Experience working in aseptic operations, protein formulation, vial and syringe filling.
* Experience working in QA Technical Support or validation functions, including experience of New Product Introductions, Technology Transfer and Process Validation activities
* Detailed Knowledge of applicable Regulatory requirements and experience with Regulatory inspections.

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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