Job Title: QA Specialist
- Participations within inter-departmental and cross-functional teams.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through quality support operations.
- Performs QA review and approval on documents that are routine in nature, where ability to recognize deviation from accepted practice is required.
- Supports development of solutions to more complex problems, identifies deviations from accepted practice and evaluates impact assessment as required.
- Involvement in investigations and corrective and preventive action (CAPA) recommendations.
- May assist in review and evaluation of proposed changes, qualification and validation documentation as related to operations.
- Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
- Participates in QA review and approval of artwork and product master data.
- May work with secondary packaging contract organisation and perform QA review and approval of associated documents.
- Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
- Normally receives very little instruction on routine work, general instructions on new assignments.
Knowledge and Skills:
- Prior experience in pharmaceutical industry is preferred (ideally within this QA role).
- Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
- Demonstrates proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and packaging requirements.
- Previous experience with change management and validation documentation is advantageous.
- Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates strong verbal, technical writing and interpersonal skills.
- Proficiency in Microsoft Office applications.
Typical Education & Experience:
- 4+ years of relevant experience in a GMP environment related field and a BS or BA.
- 2+ years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is preferred.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.