Quality Assurance Operation Specialist - Santhià (VC) - Maternity leave 12 months fixed-term co[...]

TAPI; Santhià; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company is seeking a Quality Assurance professional for a 12-month maternity leave cover in Santhià, Italy. The role involves ensuring compliance with quality standards, managing documentation, and supporting production areas. Candidates should have a relevant degree and proficiency in both Italian and English, along with some experience in the pharmaceutical sector. The position offers several workplace perks, including health insurance and professional development programs.

Servizi

Canteen

Recognition Program

Welfare Platform

Coffee token

Health insurance with access to top medical centers

Inclusive and multicultural work environment

Ongoing learning and professional development programs

Competenze

• 1-2 years of work experience in API/pharmaceutical companies.
• Proficient in Italian and English.

Mansioni

• Review batch documentation for compliance and manage disposition.
• Investigate complaints and deviations, issuing reports.
• Prepare responses to customer requests.

Conoscenze

Ability to work with autonomy

Cross-functional collaboration

Familiarity with Quality IT Systems (e.g., TrackWise)

Formazione

Bachelor’s degree in Chemistry, Pharmacy, Life Sciences or related

Descrizione del lavoro

Overview

Are you someone who enjoys working in Quality Assurance?

In this opportunity, the primary purpose of this role is to maintain the effectiveness of the Quality System at the Site, ensuring compliance and continuous improvement. This position reports directly to the Senior Manager, Quality Assurance & Qualified Person (QP).

The position is maternity leave cover for 12 months.

Responsibilities

• Batch Disposition : Review batch documentation for compliance; manage disposition of raw materials, intermediates, and final APIs.
• CAPA : Review, approve, and ensure timely execution of CAPAs to prevent reoccurrence of issues.
• Complaints : Investigate complaints; issue and review complaint reports; notify suppliers.
• Deviations : Investigate deviations; issue and review reports.
• Notifications to Management : Collect and verify information for notifications.
• Quality Customer Service : Prepare responses to customer requests; verify documentation.
• Quality Overview & Shop Floor : Monitor production and warehouse areas; ensure compliance.
• Quality Shipment / Logistics : Manage packaging and shipping documentation; review and approve packing lists.
• MS&T and RA Support : Review batch documentation and manufacturing processes for regulatory compliance.
• APR / PQR : Prepare and issue Annual Product Reviews; share with relevant sites and suppliers.
• Change Control Management : Evaluate and implement changes; review and approve risk assessments.
• Cleaning Validation Review : Review cleaning documentation for equipment.
• Document Management : Manage manufacturing procedure documentation; archive batch records.
• Process Validation Review : Review and approve validation documentation.
• Compliance Support : Participate in audits; support inspection readiness.

Qualifications

Education :

• Bachelor’s degree in Chemistry, Pharmacy, Life Sciences or closely related discipline is required.
• Alternatively, a High School Diploma completed by relevant and verified Training / Certification for the role can be accepted on an exceptional basis.

Skills :

• Able to work with a good level of autonomy with supervision where necessary
• Ability to work cross-functionally
• Familiar with Quality IT Systems : i.e. TrackWise

Languages :

• Italian, proficient English

Minimum Experience / Training required :

• 1-2 years of work experience in API / pharmaceutical companies.

Additional Information

What We Offer

• Canteen
• Recognition Program
• Welfare Platform
• Coffee token
• Health insurance with access to top medical centers
• Inclusive and multicultural work environment
• Ongoing learning and professional development programs

TAPI’s Commitment to Equal Opportunities

TAPI is committed to ensuring equal opportunities in the workplace. Our global policy provides that employment opportunities are offered regardless of age, race, religion, health status, identity, gender expression, protected categories, or any other legally recognized status entitled to protection under applicable laws.

Make Your Mark with TAPI

Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon!