Job Title:Sr Associate QC (Senior)A32253Recruiter-Neha Malik
Duration of Job:12 months Salary-34-35Euros per hour
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The Role:
Our client, a multinational bio pharmaceutical company, is seeking a Senior QC to join its expanding team in its Dun Laoghaire
This role will beresponsible for one or more of the following activities in QC including analytical testing, characterization, sample and data Besides that, this rolesupport QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as
Job Duties:
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
Sample shipments and temperature monitoring activities for NPI activities
LIMS data coordination of non-core (NPI)
Plan and perform analyses with great efficiency and
Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of
Report, evaluate, back-up/archive, trend and approve analytical
Troubleshoot, solve problems and communicate with
Initiate and/or implement changes in controlled
May train others as necessary
Participate in audits, initiatives and projects that may be departmental or organizational in
Write protocols and perform assay validation and equipment qualification/
Introduce new techniques to the lab, including method transfers, reports, validations and
May contribute to regulatory
May conduct lab investigations as
Evaluate lab practices for compliance on a continuous
Approve lab results
May represent the department/organization on various teams
May interact with outside
Create APPX data files and randomisation memo to facilitate data
LIMS data coordination of commercial and import testing on site where applicable
May provide technical May contribute to regulatory
May represent the department/organization on various May train
May interact with outside resources
Requirements
Education & Experience:
Basic Qualifications:
- Bachelor s degree in a Science related field is
- 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical
Preferred Qualifications:
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific
- Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information:Qualitative information,Quantitative research and Trend
- Understanding and application of principles, concepts, theories, and standards of GMP QC analytical Deepens technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
- Auditing documentation and operation process
- Demonstrated ability to interact with regulatory agencies
- Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to
Benefits
Benefits:
Benefit from Independent Solution s ethical principles!
Pre-interview preparation before attending the interview and help to use STAR technology to answer the
While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross-functional Life Science
We offer attractive rates - competitive margins compared to our
Payment on time and in
We are recognized as approved suppliers to leading key pharmaceutical and medical device
You must have the right to work in Ireland for this role.
If you have the above skills & experience, please contact or apply at
Independent solutions provide End to End solutions to the life sciences and we are expertise in Bio-Tech, Biopharma, and medical We are the sole source of exceptional Project managers, Engineering
Education & Experience : Basic Qualifications: Bachelor s degree in a Science related field is 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical Preferred Qualifications: Knowledge of related regulatory/industry considerations, compliance issues and/or scientific Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information: Qualitative information, Quantitative research and Trend Understanding and application of principles, concepts, theories, and standards of GMP QC analytical Deepens technical knowledge through exposure and continuous learning Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Auditing documentation and operation process Demonstrated ability to interact with regulatory agencies Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to