O pracy
Job Summary
The primary purpose of the Post-Production Quality Investigator role is to lead investigations, CAPAs and Change Controls related to our post-production manufacturing.
Responsibilities:
· Initiate, author and complete deviations and investigations related to Post-Production SOP excursions. Collaborate with post-production manufacturing and Quality to investigate errors and complete deviations and Corrective and Preventive Actions (CAPAs). Ensure timely signoff of deviations and CAPAs to enable product release.
· Facilitate and lead meetings to investigate and coordinate the resolution of post-production manufacturing investigations and CAPAs through use of Root Cause Analysis tools and risk assessments.
· Provide quick, quality-based decisions while serving as the immediate escalation path for all operational staff during post-production activities.
· Support post-production continuous improvement initiatives.
· Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics.
· Collaborate with Senior Post-Production leads to author, review or revise applicable SOPs, batch records, and other operational related documents.
· Conduct technical training for post-production manufacturing operations.
· Conduct review of post-production operations to ensure compliance to procedures.
· Other tasks and duties as assigned by Area Management.
· Investigate, document findings and influence assessment for deviations.
· Actively participate on teams with SMEs within post-production.
· Assist assigned functional area leads in driving problems to resolution.
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Set Yourself Apart: Profile/Experiences
· Skilled, flexible worker with strong people skills and an extensive background in cGMP manufacturing.
· Knowledge and experience in Current Good Manufacturing Practices (cGMP) regulations, documentation, and compliance.
· Experience leading investigations and technical writing.
· Minimum of 2 years of cGMP post-production experience.
· Direct experience in processes acclimated to post-production.
· Excellent communication and organizational skills with an ability to prioritize effectively and work cross-functionally to deliver results within established timelines.
· Must be detail oriented, able to work in a fast-paced environment
Oferujemy
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.