Our client, a medical device company in Cork are currently looking to recruit a QC Analyst for their site.
The candidate must have technical knowledge of analytical techniques and knowledge of related laboratory equipment in the area of microbiological, chemistry and biochemistry testing of Bulk API and final drug product.
The candidate must preferably have prior experience of working in an HPRA/FDA regulated facility.
GENERAL SCOPE OF RESPONSIBILITIES:
Reporting to the QC Team Leader the person will be responsible for the following;
- Performing a wide variety of activities to support the introduction of new products to the site.
- Ensures lab readiness to perform raw material, in process and release testing of new clinical and commercial products.
- Coordinates the transfer of analytical methods to the QC labs.
- Performing data review and approval.
- Providing support and advice to manufacturing on QC related topics.
- Initiating and leading investigations where required.
- Initiates and completes, CAPAs and Change Controls in accordance with site procedure
- Writes new and updates current procedures on electronic documentation system.
- Providing training to other analysts and to manufacturing personnel.
- Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc.
- Proactively identifies and implements lab process improvements.
- Supports lean initiatives in the area of lab operations, i.e. standard work, level loading,
- Supports Team leader on day to day testing operations.
KEY COMPETENCIES REQUIRED:
- Adaptable and flexible
- Collaboration and team work
- Maintains the highest standards of ethical behaviour
- Clear communication skills
- Results and performance driven
- Holds self-accountable for compliant and flawless execution
- Problem solving and attention to detail
- Good time management
- Good organisational skills
- Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise etc.,
QUALIFICATIONS AND EXPERIENCE
- The position of QC analyst requires a third-level qualification (Minimum: Primary degree in a science discipline).
- A minimum of 1 years' experience within a regulated Environment, pharmaceutical advantageous.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.
For further information on this QC Analyst role in Cork please contact Jenny Dore on 0212066287 / email@example.com
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