31 lug
|
Experteer Italy
|
Lazio
31 lug
Experteer Italy
Lazio
h3QC Microbiological Laboratory Supervisor /h3pAs QC Microbiological Laboratory Supervisor, you will lead the microbiological QC lab to ensure compliant, on-time testing and high-quality results.
You'll provide technical leadership across operations supporting pharma manufacturing and release, while driving audits, CAPAs, and continuous improvement.
You will mentor the team, optimize workflows, and partner with cross-functional groups to uphold safety and quality.
This role offers impact across regulatory compliance, product quality, and customer satisfaction in a global setting.
/pulliLead and coordinate microbiological QC testing in compliance with safety regs, approved methods, and GMP standards /liliProvide technical oversight of lab operations from raw material testing to finished product release and stability studies /liliSupport audits and inspections by coordinating cross-functional activities and ensuring timely documentation /liliDraft and review specifications, study protocols, analytical methods, and SOPs per GMP and quality standards /liliParticipate in customer meetings to discuss technical topics within microbiology /liliLead investigations of OOS/OOT, and implement CAPAs /liliOversee Method Development, Validation, and Transfer activities for projects /liliCollaborate on department budget and CAPEX; optimize lab operations /liliDrive operational excellence through Lean and PPI, mentoring, and process improvements /liliLead, coach,
and develop the team with clear objectives and performance management /liliBachelor's degree or higher in Biology, Microbiology, Biochemistry, Pharmaceutical Chemistry and Technology (CTF), or related scientific discipline /liliSeveral years of experience in Microbiological Quality Control in pharma/biotech /liliAt least 3 years in a people leadership role managing laboratory operations /liliExperience in pharmaceutical manufacturing, preferably aseptic environment /liliStrong knowledge of cGMP, FDA, EU GMP, ICH, and pharmaceutical quality systems /liliKnowledge of Quality Risk Management, risk assessment, and Root Cause Analysis /liliUnderstanding of ALCOA+ Data Integrity principles and regulatory expectations /liliExcellent technical writing skills for SOPs, investigations, methods, protocols, and regulatory docs /liliStrong leadership, problem-solving, and team management skills /liliExcellent interpersonal and communication skills; ability to engage stakeholders across levels /liliAbility to manage conflicting priorities in a dynamic team /liliProficiency with Microsoft Office, LIMS, and eQMS /liliProfessional certifications in Quality Systems, Regulatory Compliance, Lean Six Sigma, or Project Management are advantageous /li /ulAs QC Microbiological Laboratory Supervisor, you will lead the microbiological QC lab to ensure compliant, on-time testing and high-quality ... #J-*****-Ljbffr
📌 Qc Microbiological Laboratory Supervisor (Lazio)
🏢 Experteer Italy
📍 Lazio