Senior Quality Assurance Specialist
- Employer
- i-Pharm Consulting
- Location
- Republic of Ireland, Dublin
- Salary
- £42.47 - £45.18 per hour
- Start date
- 18 Jan 2021
- Closing date
- 1 Feb 2021
View more
- Discipline
- Quality
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function. The QA Specialist 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 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, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
Successful candidates will typically be educated to degree level in a Scientific or related discipline and ideally will have acquired technical skills and demonstrated competencies across a broad range of quality related disciplines. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.
General QA Specialist Responsibilities:
* Perform all activities in compliance with safety standards and SOPs
* Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/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 Policies.
* Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
* Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
* Participates in customer complaint investigations.
* Provides training and advice to staff in order for them to perform their desired functions.
Incoming QA & Disposition Function (may perform some or all of these duties)
* Provide overall quality direction and oversight for key functional areas including the Warehouse, Supply Chain, Sampling activities, and the inspection and testing of incoming materials.
* Act as Quality point of contact and decision maker for investigations, change controls, and other associated quality related activities
* Site Program Owners for site disposition activities, Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability and Product Quality Review.
* Co-ordinates and approves the preparation of reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes.
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
The knowledge and skills necessary to perform the duties of the QA Specialist are typically acquired through the following combination of education, experience and knowledge.
Basic Qualifications
* University degree. Engineering or Science related discipline preferred.
* Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Qualifications
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and proven abilities in decision making
* Strong organizational skills, including ability to follow assignments through to completion
* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
* Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
* Experience working in aseptic operations, protein formulation, vial and syringe filling.
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.
- Website
- http://www.i-pharmconsulting.com/
- Telephone
- +44 (0) 20 3189 2299
- Location
-
52 Bedford Row
London
England
WC1R 4LR
United Kingdom
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