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QC Specialist

Employer
i-Pharm Consulting
Location
Republic of Ireland, Dublin
Salary
£45.18 - £47.89 per hour
Start date
24 Sep 2020
Closing date
8 Oct 2020

View more

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

Job Details

Primary Responsibilities:
* QC Representative for site / laboratory upgrade projects
* Plan and manage QC related activities from site projects.
* QC Representative for NPI activities and routine Product meetings
* Plan and Perform non-core testing related to NPI activities
* Manage all sample management activities related to NPI activities throughout the site Sample shipments and temperature monitoring activities for NPI activities
* Create/own and approve protocols, sample plans, SOP and documentation related to NPI
* Responsible for their own training and safety compliance.
* Assist with resource management, QC Project Management and other work streams as required by the lab management.
* Authoring, executing and documenting the qualification of existing laboratory equipment in a cGMP regulated environment. Writing equipment validation protocols and associated summary reports.



Specific Job Duties:
* With a high degree of technical flexibility, work across diverse areas within QC
* Plan and perform analyses with great efficiency and accuracy.
* Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
* Report, evaluate, back-up/archive, trend and approve analytical data.
* Troubleshoot, solve problems and communicate with stakeholders.
* Initiate and/or implement changes in controlled documents.
* May train others as necessary
* Participate in audits, initiatives and projects that may be departmental or organizational in scope.
* Write protocols and perform assay validation and equipment qualification/ verification.
* Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
* May contribute to regulatory filings.
* May conduct lab investigations as necessary.
* Evaluate lab practices for compliance on a continuous basis.
* Approve lab results
* May represent the department/organization on various teams
* May interact with outside resources.
* Create APPX data files and randomisation memo to facilitate data analysis.
* LIMS data coordination of commercial and import testing on site where applicable
* May provide technical guidance. May contribute to regulatory filings.
* May represent the department/organization on various teams. May train others.
* May interact with outside resources


Basic Qualifications & Experience:


Knowledge:
* Expanding knowledge of related disciplinary areas
* Broad technical knowledge within Quality Control
o Recognizes and understands the cross-dependencies of the technologies and understands the impacts on the organization
o Enhances own knowledge through understanding business trends and objectives
* Knowledge of industry and business principles
o Understands the core business process and purpose of the functional area in the company's commercialization process
* Familiarity with change management approaches, tools, and methodology
o Strong facilitation skills and presentation skills
o Ability to work and collaborate with various levels within the organization and influence cross functionally.
* Routine resource management, QC Project Management and other work streams as required by the lab.
o Developing, maintaining, tracking, and managing high quality, integrated plans to enable accurate reporting and decision making to reflect the immediate and long-term needs of each project.

Problem Solving:
* Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information
o Qualitative information
o Quantitative research
o Trend data
* Forecasts, models, and utilizes advanced analytical tools
* Anticipates and prevents potential problems
* Creates new procedures and processes to drive desired results
* Handles diverse scope of issues that require evaluation of a variety of factors including current business trends

Autonomy:
* Works under minimal direction
* Work is guided by operational and project objectives
o Manages multiple assignments and processes
o Independently determines approach to project
* May be responsible for specific programs and/or projects
* Independently develops solutions that are thorough, practical, and consistent with functional objectives


Skills:
* Take initiative to identify and drive improvements
* Communication skills (verbal and written) at all levels
o Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
o Presentation skills
o Escalate issues professionally and on a timely basis
* Decision making
* Teamwork and Coaching others
* Teamwork and Coaching others
* Auditing documentation and operation process
* Demonstrated ability to interact with regulatory agencies
* Independently develops solutions that are thorough, practical, and consistent with functional objectives

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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