Requirements
Requires a Bachelor's degree in Pharmacy or Science, with 7+ years of relevant QA experience in the pharmaceutical industry. Must have strong knowledge of cGMP, GDP, quality systems, and regulatory requirements, with solid experience in sterile manufacturing, contamination control, regulatory inspections, audits, and supplier/service provider qualification. Strong leadership, communication, analytical, and problem-solving skills are essential.
Description
QA Compliance LeadJob PurposeLead site QA compliance activities and ensure adherence to cGMP, GDP, regulatory requirements, and company quality standards.Key Responsibilities* Ensure site readiness for regulatory and internal inspections and audits.* Oversee quality systems including Deviations, CAPAs, Complaints, Recalls, and Audits.* Lead internal audits and self-inspections and ensure timely closure of findings.* Monitor compliance and drive continuous improvement initiatives.* Ensure compliance of sterile manufacturing activities and contamination control practices.* Lead qualification of suppliers and service providers for manufacturing and auxiliary materials.* Promote quality awareness and a strong compliance culture across the site.* Provide guidance and support to QA team members and cross-functional teams.Requirements* Bachelor's degree in Pharmacy, Science, or a related field.* 7+ years of relevant QA experience in the pharmaceutical industry.* Strong knowledge of cGMP, GDP, quality systems, and regulatory requirements.* Solid experience in sterile manufacturing and contamination control.* Experience in regulatory inspections, audits, and supplier/service provider qualification.* Strong leadership, communication, analytical, and problem-solving skills.* Good command of English.https://career55.sapsf.eu/sfcareer/jobreqcareerpvtjobId=2560&company=pharcophar&st=389C0EF3C12573C7A8DF629715876933ED4D9981