TAPI - Senior Quality Assurance Specialist

TN Italy; Caronno Pertusella; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Quality Assurance professional who is detail-oriented and passionate about product quality. In this role, you will ensure that every product released meets the highest standards of quality and compliance. Your responsibilities will include reviewing batch documentation, investigating complaints, and managing quality oversight on the shop floor. You will collaborate cross-functionally and support regulatory audits, making a significant impact on the quality system at the site. If you have a background in chemistry or life sciences and a knack for problem-solving, this is an exciting opportunity to enhance product reliability.

Competenze

• 3-6 years of experience in API/pharmaceutical companies.
• Bachelor’s degree in Chemistry or related field is required.

Mansioni

• Review batch documentation for compliance before disposition.
• Investigate complaints and deviations with quality team.

Conoscenze

Autonomy in work

Cross-functional collaboration

Familiarity with Quality IT Systems

Formazione

Bachelor’s degree in Chemistry

High School Diploma with Training/Certification

Strumenti

TrackWise

Descrizione del lavoro

Job Description

The opportunity

Are you passionate about ensuring products meet the highest standards? Do you have an eye for detail and a knack for identifying potential issues before they become problems? Imagine being a key player who contributes to guaranteeing that every product released is flawless and reliable.

Reporting to the Quality Assurance Manager, you will contribute to maintaining the effectiveness of the Quality System at the site.

How you’ll spend your day

1. Batch Disposition: Review batch documentation for compliance before disposition and manage disposition of raw materials, intermediates, and final APIs with Qualified Person's support.
2. CAPA: Review, approve, and ensure timely execution of CAPAs to prevent reoccurrence of issues and implement remediation actions assigned to Quality Assurance.
3. Complaints: Investigate complaints with Site Quality Head, Qualified Person, and QA Manager; issue and review complaint reports; notify suppliers of complaints.
4. Deviations: Investigate deviations with Site Quality Head, Qualified Person, and QA Manager; issue and review deviation reports; support investigations.
5. Notifications to Management: Collect and verify information for management notifications.
6. Quality Customer Service: Prepare responses to customer requests, verify documentation, and set due dates with Customer Service.
7. Quality Oversight & Shop Floor: Ensure quality oversight and monitoring at the shop floor; participate in Quality Walk Arounds; audit production and warehouse operations for compliance.
8. Quality Shipment/Logistics: Manage and review packaging and shipping documentation; approve packing lists with Qualified Person's support.
9. MS&T and RA Support: Review batch documentation per regulatory requirements; verify manufacturing and packaging processes align with DMF.
10. APR/PQR: Prepare and issue Annual Product Reviews; share schedules with other sites and suppliers; review APRs provided by service suppliers.
11. Change Control Management: Evaluate and implement changes with Site Quality Head, Qualified Person, and QA Manager; issue, review, and approve risk assessments for change controls.
12. Cleaning Validation Review: Review documentation for equipment cleaning procedures.
13. Document Management: Manage and distribute manufacturing procedures and master batch records; archive executed batch records.
14. Process Validation Review: Review and approve documentation for manufacturing process validation.
15. Compliance Support: Participate in regulatory audits and support Inspection Readiness Plans.
16. Ethical Conduct: Behave according to the company's Ethical Code and values; support employee motivation and development.

Your experience and qualifications

Education:

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

Skills:

• Ability to work with a good level of autonomy, with supervision where necessary.
• Ability to work cross-functionally.
• Familiarity with Quality IT Systems, such as TrackWise.

Languages & Experience:

• Minimum 3-6 years of work experience in API/pharmaceutical companies.

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