Quality Assurance Compliance Lead

1 mese fa

Caronno Pertusella, Italia Teva Pharmaceuticals A tempo pieno

Opportunity Overview

The role involves overseeing post-marketing operations for pharmaceutical ingredients previously manufactured at a designated site.

Your focus will be on sustaining business processes and subsystems aimed at meeting established quality benchmarks while enhancing overall operational effectiveness.

Key responsibilities include maintaining current policies, processes, and documented information.

You will be tasked with implementing and upholding essential quality management objectives.

Daily Responsibilities

Main Duties:

Oversee post-marketing operations for pharmaceutical ingredients:


• Ensure thorough investigation and resolution of quality-related complaints;

• Conduct product quality assessments and stability evaluations;

• Manage product recalls in accordance with established procedures and regulations;

• Perform quality risk assessments as necessary;

• Handle product returns following company protocols;

• Oversee notifications to management and quality assurance measures, ensuring completion and closure;

• Coordinate the dispatch of batches from external storage facilities;

• Update quality technical agreements as required;

• Collaborate with Regulatory Affairs to ensure compliance and accuracy of regulatory documentation;

• Serve as the quality liaison with both internal and external stakeholders regarding quality technical agreements, supplier qualifications, issue resolution, and product specifications;

• Issue compliance statements for products, ensuring adherence to current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and data integrity standards.

Manage compliance activities for additional sites:


• Process documentation through generation, modification, review, and approval workflows (SOPs, test methods, specifications, protocols, reports, etc.);

• Track, trend, and report quality metrics to monitor site performance;

• Review regulatory and quality compliance requirements, perform gap assessments, and enhance SOPs as necessary;

• Develop and monitor corrective action plans when required;

• Assist Regulatory Affairs with updates to regulatory registrations;

• Manage tracking of GMP training to support site performance;

• Define standard operating procedures and skill matrices;

• Review, approve, and ensure timely execution of corrective and preventive actions (CAPAs) to prevent recurrence of issues identified during audits and reviews;

• Implement assigned remediation actions effectively;

• Support investigations of notified complaints in collaboration with the Site Quality Head and Qualified Person;

• Prepare complaint reports with input from subject matter experts;

• Notify suppliers of any complaints identified during internal investigations;

• Review complaint reports from suppliers;

• Assist in compliance-related investigations and prepare reports with input from subject matter experts;

• Coordinate and support departmental investigations and review deviation reports;

• Identify requirements for site licensing with regulatory bodies;

• Assist in gathering information for notifications;

• Conduct internal audits and participate in external compliance audits;

• Support execution of the Inspections Readiness Plan;

• Establish and review quality technical agreements with customers;

• Assist in drafting and maintaining a Site Master File.

Qualifications and Experience

Education and Skills:


• A degree in pharmaceutical sciences, chemistry, healthcare, or a related field;

• Comprehensive understanding of current GxP regulations and guidelines (EU, US, ICH);

• Insight into various aspects of quality and compliance functions;

• Familiarity with regulatory standards in the API industry and expectations from global regulatory bodies;

• Knowledge of quality systems and manufacturing processes;

• Preferred: experience with operational excellence and project management tools.

Skills:


• Ability to work autonomously;

• Strong cross-functional collaboration skills;

• Competence in adhering to quality manufacturing standards and regulatory requirements;

• Proficiency in risk management and promoting continuous improvement.

Language Proficiency:

Fluent in Italian and English.

Experience Requirements:

Over 5 years of relevant experience in a GxP environment focusing on quality and compliance.

What We Offer

We prioritize the well-being of our employees by providing a range of benefits, both large and small. For instance:

Type of contract: Long-term contract.

Location and Work Schedule

This position is based in a designated area, with responsibilities extending to other sites as needed.
Work schedule: Monday to Friday.

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