Join a dynamic team within the QC function and contribute to the vision of becoming a global leader in pharmaceutical products. This key role within the Quality Control area offers an opportunity to drive efficiency, compliance, and excellence in pharmaceutical manufacturing.
Key Responsibilities:
- Review routine and non-routine analyses of materials and finished products.
- Interpret test results and make recommendations based on established specifications.
- Verify documentation and ensure compliance with regulations and best practices.
- Participate in investigations and recommend corrective actions.
- Support data necessary for regulatory submissions.
- Train analysts and ensure adherence to laboratory procedures.
- Identify quality issues and propose solutions.
- Monitor testing procedures and ensure compliance with standards.
- Serve as a technical liaison with other departments and vendors.
- Write or revise standard operating procedures.
Competencies:
- Strong experience in analytical lab analysis in QC within pharmaceutical manufacturing.
- Knowledge of analytical methodologies and instrumentation (UPCL, HPLC, GC, etc.).
- Proficiency in Chromatography Data Software Empower.
- Experience in method transfers and data integrity management.
- Familiarity with cGMP, FDA guidelines, and regulatory requirements.
- Proactive attitude and willingness to learn.
- Strong time management and organizational skills.
- Ability to work effectively in a team.
Qualifications:
- Master's degree in chemistry or similar scientific field.
- Excellent communication and troubleshooting skills.
- Proficiency in MS Word and QC Lab software.
- Demonstrated mathematical and statistical skills.
- Fluency in English, both verbal and written.
Apply now to embark on a rewarding career journey; send your CV for more information to me at annemarie@amfconsulting.ie