QA Compliance Lead

QA Compliance Lead

Job Purpose

Lead 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