Description
QC Analyst - Pharmaceutical/Cork, Ireland/11 Months Contract/Up To 27 EUR Per Hr.
Candidates must have superior 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 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.
QC rep on site NPI teams and global analytical teams related to specific projects and products
Ensures lab readiness to perform raw material, in process and release testing of new clinical and commercial products.
Co-ordinates 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, ie, internal investigations and regulatory inspectors etc.
Proactively identifies and implements lab process improvements.
Supports lean initiatives in the area of lab operations, ie 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
ESSENTIAL:
The position of QC analyst requires a third-level qualification (Minimum: Primary degree in a science discipline).
A minimum of 4 years experience within the Pharmaceutical Industry
Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products. Significant HPLC Experience critical to meet team requirements.
The Company
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.