Senior QA Associate
- Employer
- i-Pharm Consulting
- Location
- Republic of Ireland, Dublin
- Salary
- £251.82 - £260.21 per day
- Start date
- 16 Jul 2019
- Closing date
- 30 Jul 2019
View more
- Discipline
- Manufacturing
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
Description:
Ideally to start ASAP
Investigating and complaints
Batch review
Key candidate must haves:
Excellent written and verbal communication
Experience working cross functional
Demonstrated ability for problem solving
Background, ideally within pharma either manufacturing, Quality, QC
Previous experience with batch review/investigations (min of 2 years experience) or willing to consider graduate at Masters or PhD level
Ideally some complaints handling
Overview:
The Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Manager and is a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
Key Responsibilities:
* Perform all activities in compliance with company safety standards and SOPs
* Write, review and approve Standard Operating Procedures in accordance with company policies.
* Investigate Product Complaints
* Provide Quality support for triage and investigation of Deviations
* Review and approval of Deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
* Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
* Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
* Review and approve cGMP records (e.g., deviations, CAPA, protocols, reports & SOP) ensuring compliance with appropriate documentation
* Support continuous improvement and Operational Excellence initiatives
* Any other tasks/projects assigned as per manager's request.
Basic Qualifications & Experience:
* University degree. Engineering or Science related discipline preferred.
* Relevant experience (2 yrs +) 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 & Experience:
* 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
* Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
* Operational Excellence experience
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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