Quality Operations Coordinator

ITA - 8290 Takeda Manufacturing Italia S.P.A.; Rieti; On-site; EUR 31,000 - 43,000; Full time

Job summary

Takeda Manufacturing Italia S.P.A. in Italy (Rieti) is seeking a Quality Oversight professional to verify batch records, ensure GMP compliance, and collaborate with Production to close gaps. The role emphasizes data integrity and leadership in quality processes across the production site.

The candidate should hold a scientific degree, have strong English skills, and demonstrate knowledge of GMP and manufacturing principles. The position is full-time and based on site in Rieti.

Qualifications

• Degree in scientific discipline or equivalent with knowledge of pharmaceutical regulations.
• Good command of English (written and spoken).
• Strong knowledge of manufacturing processes, quality principles, and GMP/CgMP requirements.

Responsibilities

• Review and ensure execution of quality batch record review per SOPs and regulations.
• Open and manage events identified during batch record review or reported by production operators.
• Review production procedures and master batch records.
• Identify improvement opportunities and implement CAPAs to improve GMP compliance.
• Collaborate with Production to identify and resolve compliance gaps and ensure traceability of GMP documentation.
• Lead or support development projects to deepen knowledge of production activities.
• Ensure GMP documentation management, including archiving, data collection, and destruction of documents.
• Prepare equipment cleaning samples and verify plasma receipt compliance.

Skills

GxP knowledge

English skills

Quality leadership

Problem solving

Data integrity

Education

Scientific degree

Job description

Job Description Previa verifica dei requisiti professionali, costituisce titolo preferenziale l’appartenenza alle Categorie Protette ai sensi dell’art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo e/o lavoratori delle aziende del territorio di riferimento coinvolte da tavoli di crisi attivi presso il MIMIT.

OBJECTIVES/PURPOSE

Verifies and ensures compliance with GxP and site procedures, defining and maintaining collaboration between Quality and Production. Verifies and ensures product quality in accordance with regulatory requirements and standard operating procedures. Promotes and disseminates quality principles within the Production department.

ACCOUNTABILITIES

• Review and ensure the execution of quality batch record review in compliance with SOPs and regulations.
• Open and manage events identified during batch record review and/or reported by production operators.
• Review production procedures and master batch record.
• Identify improvement opportunities and implement appropriate CAPA to increase GMP compliance in production areas.
• Actively collaborate with Production to identify and resolve compliance gaps, both documentation-related and on the shop floor.
• Lead/execute development projects aimed at deepening knowledge of production activities.
• Ensure GMP documentation management, including archiving, data collection, and document destruction.
• Prepare equipment cleaning samples.
• Verify the compliance of plasma receipt requirements.

CORE ELEMENTS RELATED TO THIS ROLE

What differentiates this role and represents its core elements is Quality Oversight: ensuring batch record review, data integrity of production systems, and the management of events, changes, and CAPAs; collaborating with Production to resolve compliance gaps and ensure traceability and control of GMP documentation.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise Required: Degree in scientific discipline and knowledge of pharmaceutical applicable regulations, or demonstrated/approved knowledge of manufacturing processes. Good command of English. Excellent knowledge of the manufacturing process and quality principles. Leadership Be positive Be accountable Be results-oriented Good communication skills Problem-solving attitude Good teamwork skills Good knowledge of cGMP Decision-making and Autonomy Good ability to work independently Interaction Good communication and negotiation skills Innovation Good ability to optimize workflows in classified areas Complexity Direct interface with Production, Maintenance, Calibration, and Quality personnel

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Good command of English (written and spoken) Excellent analytical and problem-solving skills Excellent communication, negotiation, and leadership skills Excellent technical writing skills and presentation skills.

Locations ITA - Rieti Base Salary Range: €31,200.00 - €42,900.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Worker Type Employee Worker Sub-Type Regular Time Type Full time

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives - including your own.

Takeda is an equal opportunity employer.