QC Specialist (Investigations)
- Employer
- i-Pharm Consulting
- Location
- Republic of Ireland, Dublin
- Salary
- £38.86 - £42.47 per hour
- Start date
- 14 Apr 2021
- Closing date
- 28 Apr 2021
View more
- Discipline
- Quality, QA / QC
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
This job specification outlines the general responsibilities associated with the role of QC Investigations Specialist. The successful candidate will join the investigations team as a senior member of the team. Continuous Improvement with regard to investigations and error management will be key areas of focus for the role. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the QC support function.
Key Responsibilities
* Champion for Investigations in Quality Control
* Owns and Manages Investigations for QC through QMTS
* Authors and reviews investigation reports
* Participates routinely in the investigation triage process
* Ensures investigations are kept up to date and compliant with procedures
* Ensure investigations result in robust CAPA to prevent recurrence
* Seeks out opportunity to improve the process and management of Investigations
* SME for error management and error reduction in QC
* Lead improvement initiatives as required e.g. PPI
* Strong focus on RFT and Lean
* Key contact for Investigation Metrics
* Provides coaching, support and mentoring on investigations to the investigation team
* Responsible for on time co-ordination of QC Investigation Trend reports
* Builds relationships and partners with similar roles at ADL and in the network to share lessons learned and improvements
* May own Change Controls linked to investigations and CAPAs
* May provide support for Protocol generation linked to QC Investigations
* Supports Audits and Inspections with regard to preparation and participation
* Represents QC at site and network level with regard to Investigations and Error Management.
* Works with minimal supervision but knows when to escalate or look for support
* May co-ordinate the Investigation team workload such that investigations are prioritized as required and delivered within due dates. Escalates as required.
Knowledge and Experience:
* Hold a third level qualification in Science related discipline
* Have minimum 6 years' experience in Biotechnology/ Pharmaceutical setting
* Possess key competencies to include Planning and Organisation, Communication, Teamwork, Flexibility
* Excellent Technical Writing skills
* Proficient in Root Cause Analysis
* Detailed knowledge of the QC function and is operationally savvy
* Proven Experience of handling GMP investigations within a Quality System
* Demonstrated Leadership attributes: Delivers Results
* Knowledge of Error Management Methodologies and experience with Six Boxes Approach advantageous
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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