Post Production Quality Investigator VI

Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries.

The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient.

From our position as market leader, we act locally and think internationally.

The primary purpose of the Post-Production Quality Investigator role is to lead investigations, CAPAs and Change Controls related to our post-production manufacturing, specifically involving visual inspection.

Responsibilities:

• Initiate, author and complete deviations and investigations related to Post-Production Visual Inspection events. 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 visual inspection investigations and CAPAs through use of Root Cause Analysis tools and risk assessments.

• Investigate via camera review, production errors, inspector audits, etc.

• Provide quick, quality-based decisions while serving as the immediate escalation path for all staff associated with visual inspection.

• Support post-production continuous improvement initiatives.

• Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics.

• Track and trend visual inspector metrics involving inspection times, components, rejection rates, identified defects, etc.

• Collaborate with visual inspection management to author, review or revise applicable SOPs, batch records, and other operational related documents.

• Assist with technical training for post-production visual inspection operations associated with common errors or concerns.

• 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 visual inspection.

• Assist assigned functional area leads in driving problems to resolution.

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 with visual inspection processes, training and documentation.

• Prefer 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.

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.

Apply online through careers.fagron.com.