Head of Quality Control

2 settimane fa

Lazio, Italia Confidenziale A tempo pieno

The company Our client is a multinational pharmaceutical company. For an Italian plant with several hundred resources, in phase of great growth and development.
Place of work:
south of Rome

The role

The QC Manager (Head of Quality Control) will serve as a strategic and tactical role in ensuring oversight and execution of all aspects of GMP related QC testing. The role is responsible for ensuring oversight of the Sites laboratory (starting materials, in-process, release, and stability testing and environmental monitoring of controlled areas) and contract laboratories.
The Head of Quality Control supports Company's quality culture through collaborating externally and with Analytical Development, Manufacturing Operations, Product Development and other internal stakeholders to ensure products meet the required specifications and QC data integrity principles are applied and maintained for late phase and commercial programs.

The QC Manager will manage a team of several dozen resources.

Responsibilities include:
Ensures QC performs release testing of products (sterile, non-sterile), raw materials, packaging components, stability studies, environmental monitoring
Contributes to the development and maintenance of a positive, team-focused company culture and a culture of quality by collaborating across all departments and levels of management to accomplish company objectives and represent QC
Ensures the QC meets or exceeds Companys standards for data integrity
Establishes processes and ensures collection, analysis, assessment and approval of data to support annual product quality reviews, specifications, stability, and product quality trending
Ensures QC provides analytical support for process and cleaning validation, and process deviations
Directly interfaces with contract laboratories, regulators and Quality Assurance in support of internal and external audits and inspections of the Site, including inspection readiness activities
Identifies opportunities for improvement of methods, processes, and systems to assure the quality of testing of product manufactured at the Site. Provides input and change management ownership for quality improvements affecting QC methods and processes
Development and implementationof testing-related Quality Management System processes. Create, maintain, and revise QC SOPs and documents that support the Quality Management System
Ensure that the QC organization meets key performance indicator goals. Includes meeting and exceeding internal stakeholder and customer expectations
Builds and maintains expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities where required.
Assess and evaluate the introduction and replacement of equipment
Ensure Technical support to the Purchasing Department for consumer materials by analyzing new proposals from providers, introducing more efficacious ingredients, supporting the description in the specification of the supply and the certification of providers so to meet the efficiency and efficacy target related cost savings.
Supports the QP by providing the information needed to release the batch and reporting quality events like (deviations, out of specifications) that constitute a risk to product quality or compliance. Ensuring that all the information needed by the QP is promptly reported
Collaborates with the Analytical Development team for activities related to technology transfer and analytical method validation
Ensures that deviations are appropriately investigated, and that corrective and preventive actions are effectively implemented

**Requirements**:
The position requires a BS or BA degree or equivalent in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology or equivalent science program Minimum of 8 years of experience in the pharmaceutical industry (with experience leading a Quality Control function) ideally covering the analytical method and testing lifecycle from development through commercial product testing, with at least 5 years in a GMP QC release testing role Significant experience in an FDA and EMA regulated environment Broad knowledge of QC processes and procedures, LIMS systems, and GMP regulations and guidance with demonstrated effectiveness in maintaining QC processes for compliance with regulations Experience leading analyst teams with a total team size of at least 50 people

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