Job Title: Quality Compliance Manager
Location: Rho, Italy
Company: Teva Pharmaceuticals
Job ID: 59444
Date Posted: November 27, 2024
Who We Are
Teva Active Pharmaceutical Ingredients (TAPI) is a leading global supplier of APIs, offering a diverse portfolio of over 350 products. With a legacy spanning over 80 years, TAPI serves 80% of the top 50 global pharmaceutical companies and operates across 14 state-of-the-art facilities worldwide.
Our success is driven by 4,000 dedicated professionals, fostering innovation and maintaining high standards in research, production, and customer service.
Job Purpose
This role involves developing and maintaining quality programs, systems, and procedures to ensure compliance with regulations and standards, specifically focusing on Quality Control activities, documentation management, and data integrity.
The Quality Compliance Manager reports to the Site Quality Head and contributes to the site's inspection readiness, compliance initiatives, and continuous improvement.
Main Responsibilities
Quality Compliance:
Ensure adherence to site procedures and divisional policies, promptly addressing non-compliance.
Review regulatory and quality compliance requirements and develop gap assessments, SOPs, and corrective action plans.
Align local SOPs with cGMP guidelines and support staff training on policies and procedures.
Assist in managing Notifications to Management (NTMs) and Global Notifications to Management (GNTMs).
Collaborate with Regulatory Affairs, Site Quality Head, and the Qualified Person on regulatory documentation.
Inspection Management:
Support Regulatory Authority inspections, self-inspections, and external audits (customers and GRA).
Communicate, track, and resolve audit observations, ensuring CAPA plans are implemented effectively.
Inspection Readiness:
Assess regulatory compliance and implement CAPAs to ensure continuous adherence.
Conduct compliance reviews based on observations from other Teva sites and oversee Quality Walk Around activities on the shop floor.
Compliance for Quality Control:
Monitor and implement requirements from Pharmacopoeias Compendial Updates.
Support QC Manager with documentation for suitability and equivalency studies.
Review and audit data and audit trails periodically.
General Responsibilities:
Uphold Teva’s Ethical Code and core values.
Identify and implement continuous improvement opportunities in collaboration with Quality leadership.
Assist the Qualified Person (QP) in regulatory compliance activities under Italian law (D.L. 219/06).
Safety Responsibility:
Act as Preposto per la Sicurezza under Italian law (D.Lgs 81/2008), ensuring workplace safety directives are followed and effectively monitored.
Requirements
Experience: Minimum 5 years in quality management, with a focus on compliance.
Education: Scientific degree (Chemistry/CTF), preferably a master's in Regulatory Sciences.
Skills:
Proficient in computer systems.
Fluent in Italian and English.
Preferably recognized as a Qualified Person (AIFA).
Pharmaceutical industry background.
What We Offer
Teva values its employees and provides a range of benefits:
On-site canteen.
Flexible work arrangements for caregivers and parents.
Welfare platform and recognition programs.
Health agreements with premium medical centers.
Hybrid working model: 2 days remote per week.
Access to LinkedIn Learning and continuous development programs.
Inclusive and multicultural work environment.
Contract Type: Long-term contract
Work Schedule: Monday to Friday
Location:
Rho (Milan), Italy
Teva’s Commitment to Equal Opportunities
Teva is dedicated to providing equal employment opportunities, fostering an inclusive and diverse workplace free from discrimination based on age, gender, race, religion, health status, or any legally recognized protected category.
Join Teva and make a meaningful impact in pharmaceutical quality and compliance!
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