Senior QC Micro Analyst
This job has been filled.
Engineering and Technical
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Dependent on Experience
13-12-2019 01:22 PM
SCM S1
New Opportunity - Senior QC Micro Analyst
Established pharmaceutical company looking to bring on a Senior QC Micro Analyst to manage and co-ordinate QC department tests for the release of raw materials, in-process products, bulk drug substance, final products.
As the Senior QC Micro Analyst your duties and training will include:
Duties:
- Supervise microbiology laboratory activities and analysts
- Liaise in Quality Control microbiological techniques and processes
- Support preparation, technical review and approval of analytical methods (SOM's) and analysis sheets (AAS) for QC microbiology.
- Technical review, assessment, approval and trending of Environmental Monitoring data
- Support equipment periodic reviews, QC system owners, validation and qualification of new equipment.
- Technical expert in major CAPA and procedural updates
- Be accountable and responsible for supporting QC, site audit readiness, QMS documentation closure OTIF
Requirements:
- Degree qualified in a Science Discipline - Chemistry, Biology.
- Experience within a QC microbiology laboratory working to GMP within a recognised quality system.
- Manage a team and schedule/work to SOP documentation.
- Knowledge of GMP guidelines and regulatory bodies.
Skills:
- Environmental monitoring and associated microbiology knowledge would be advantageous.
- Batch release and stability testing to GMP and in accordance with Annex 11 Computerised Systems and 21 CFR part 11 and Data Integrity requirements
As the Senior QC Micro Analyst, you will have the chance to develop your skills and progress with an innovative company, focused on both self-development and business development.
Please update your CV, click & apply first, then call Sean at Connect Appointments Technical on 01324464951.
INDTECH