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Senior Plant Quality Assurance Associate

Employer
i-Pharm Consulting
Location
Republic of Ireland, Dublin
Salary
£209.85 - £251.82 per day
Start date
15 May 2019
Closing date
29 May 2019

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

Job Details

Description:


Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, method development, sample and data management and equipment maintenance.
* Contributes to team by ensuring the quality of the tasks/services provided by self
* Contributes to the completion of milestones associated with specific projects or activities within team

This role will support manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Specific Job Duties:
* With a high degree of technical flexibility, work across diverse areas within the lab
* Plan and perform routine analyses with 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.
* 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.
* Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
* Approve lab results
* May participate in lab investigations.
* May provide technical guidance.
* May train others.
* May contribute to regulatory filings.
* May represent the department/organization on various teams
* May interact with outside resources.

Knowledge:
* Experience in a wide variety of analytical techniques including but not limited to HPLC, Gels or
Capillary Electrophoresis.
* Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

Skills:
* Take initiative to identify and drive improvements
* Excellent verbal and written communication skills
a. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
b. Presentation skills
c. Escalate issues professionally and on a timely basis
* Decision Making skills
* Teamwork and Coaching others
* Negotiation and Influence skills
* Problem solving skills
a. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
i. Ensures compliance within regulatory environment
ii. Develops solutions to technical problems of moderate complexity
iii. Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
b. Interprets generally defined practices and methods
c. Able to use statistical analysis tools to perform data trending and evaluation
* Project Management and organizational skills, including ability to follow assignments through to completion
Competencies:
* Demonstrated ability to work independently and deliver right first time results
a. Works under minimal direction
b. Work is guided by objectives of the department or assignment
i. Follows procedures
ii. Refers to technical standards, principles, theories and precedents as needed
iii. May set project timeframes and priorities based on project objectives and ongoing assignments
iv. Recognizes and escalates problems
* Demonstrated leadership and communication skills
* Auditing documentation and operation process
* Demonstrated ability to interact with regulatory agencies
Relevant experience:
* Bachelor's degree in a science discipline.
* 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
* Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.

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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