Associate QC

Found in: Talent IE C2 - 2 weeks ago

Dublin, Ireland TEAM HORIZON Full time
Description

Team Horizon is seeking a CW Sr Associate QC (Senior) for our client based in Dublin. Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management. 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 QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.



Why you should apply:



This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:



QC Representative for NPI activities and routine Product meetings
Assist with activities related to QC projects and/or QC tasks within Site projects
Plan and perform non-core testing related to NPI activities
Manage all sample management activities related to NPI activities throughout the site
Create/own and approve protocols, sample plans, SOP and documentation related to NPI
QC Representative responsible for Method Validation and Transfers co-ordination and readiness
Responsible for their own training and safety compliance.
Sample shipments and temperature monitoring activities for NPI activities
LIMS data coordination of non-core (NPI) activities..
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
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

What you need to apply:



Bachelor’s degree in a science discipline. 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
Strong background in Chemistry and Analytical testing is required.
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
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
Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information o Qualitative information o Quantitative research o Trend data •Anticipates and prevents potential problems Skills:
Auditing documentation and operation process Competencies:
Demonstrated ability to work independently and deliver right first-time results.
Works under minimal direction b. Work is guided by objectives of the department or assignment.
Refers to technical standards, principles, theories, and precedents as needed.
Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues.
Auditing documentation and operation process
Demonstrated ability to interact with regulatory agencies Relevant experience:
Bachelor’s degree in a Science related field is required.
5+ 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 cGMP manufacturing and testing of pharmaceutical products.

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