Your new company

Your new role

• Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
• Reviews routine manufacturing, QC and engineering documentation including batch manufacturing records
• Assists in the completion of manufacturing related customer complaint investigations
• Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents
• Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
• Review and approval of GMP Deviation investigations and CAPAs
• Identifies problems and generates alternatives and recommendations
• Completion of routine/non-routine to more complex projects/assignments
• Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance with GMP
• Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings
• Normally, he receives very little instruction on routine work, and general instructions on new assignments.

What you'll need to succeed

• 4+ years of relevant experience in a GMP environment related field and a BS or 2 + years of relevant experience and an MS.
• Prior experience in the pharmaceutical industry is preferred (ideally within a QA role).
• Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
• Demonstrates working knowledge of quality assurance systems, methods and procedures.
• Basic knowledge of OPEX Lean tools, and root cause analysis tools are used for identifying and correcting deviations.
• Demonstrates audit and investigation skills, and report writing skills.
• Good verbal, written, and interpersonal communication skills.
• Proficiency in Microsoft Office applications.

What you'll get in return

• Opportunity to gain experience with a recognised global entity which will enhance your future career prospects.
• Work in a department with like-minded professionals working towards a common goal for a company with an excellent reputation.
• Competitive contract rate

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.