Job Reference: FRS22239
Job Duration:
Start date: 10/10/2018
Description:
A leading pharmaceutical company in Dublin West now has a fantastic opportunity for a QC Analyst Microbiology to work in a FDA regulated environment .This award winning company has an excellent history of employee, continuous professional development and business continuous improvement.
QC Analyst Microbiology Job
Duties:
* Oversee microbiology andcoordinate sampling activity in support of routine testing.
* Coordinate and priorities laboratory activity in support of routine testing, product release, product shelf-life, process non-conformances, complaint investigations, regulatory submissions
*Act as a technical expert and approval authority on relevant technical issues, protocols, SOPs, methods,
* Implement cost improvement projects within department and in support of internal customers.
* Perform microbiological testing
* Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
* Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.* Provide training & development to junior analysts.
* Ensure that any Out of Specification (OOS) or Out of Trend (OOT)analytical results are managed as per SOP.
* Perform environmental monitoring as required to support operations.
* Track, report, & improve key quality indicators for laboratory compliance and efficiency.
* Perform other related duties as assigned by management.
* Acts as the contact for regulatory groups on scientific issues and audits.
Requirements- QC micro Analyst Job
* Level 8 Bachelor's Degree in a science related field.
* Min 3 years' experience working in Microbiology in a sterile/aseptic manufacturing company preferably in a Biologics company
* Experience of microbiology testing including Sterility,endotoxin, mycoplasma and Environmental Management
* Experience of working in a GMP environment.
* Thorough knowledge of FDAand International Regulatory requirements.
* Excellent organizational, interpersonal, written and oral communication skills required.
* Ability to work on own initiative and flexible work ethic
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Industry: Science and Research
Salary: Benefits, Bonus
Salary Benefits: Benefits, Bonus
Vacancy Type: Permanent
Job Skills: Microbiologist JobDublin, QC micro job Dublin , Microbiologist job , QA Manager, Quality supervisor, QA supervisor, microbiology Manager
Contact Name: Felicity Farrell
Website: -
Direct Application URL: -