Quality Assurance Operations Technician - Temporal Apply

3+ years

Not Disclosed

Barcelona

10 Jan. 28, 2025

Job Description

Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Assurance Operations Technician (Temporary)
Location: Barcelona Palafolls (Sandoz)
Time Type: Full-Time
Posted On: Today
Job Requisition ID: REQ-10037946

Job Overview

Sandoz, a global leader in the generics antibiotics sector, is seeking a Quality Assurance Operations Technician (temporary position). The role involves ensuring compliance with GMP standards and supporting the implementation of quality systems across the Sandoz Industrial Products (SIP) plant in Palafolls. You will be responsible for overseeing the quality assurance of manufacturing processes, reviewing batch records, and ensuring the proper handling of APIs and raw materials.

Key Responsibilities

Batch Record Review: Review batch records of products manufactured at Sandoz Industrial Products SA, ensuring compliance with established quality system procedures and current records.
API Release & Quarantine: Release APIs produced at Sandoz I.P. Palafolls and authorize shipments from quarantine.
Process Oversight: Ensure GMP compliance in chemical processes and support the proper implementation of Novartis quality requirements in manufacturing systems at Sandoz I.P. Palafolls.
Deviation Management: Monitor and approve investigations related to deviations, OOS (Out of Specification), OOE (Out of Expectation), and OOL (Out of Limits).
KPI Monitoring & Trend Analysis: Track key performance indicators (KPIs) and analyze trends related to quality assurance activities.
HSF Review: Review HSF (Health Safety and Environment) of sterile APIs and decide on the use of API lots based on quality specifications.
Raw Materials & Intermediates: Ensure that raw materials and intermediates used in production are reviewed and released in compliance with quality standards.
Analytical Reviews: Request additional analysis if required due to production incidents.
Quality Standards Application: Apply and interpret quality standards (Guidelines, SOPs, Manual of Quality, etc.) to ensure GMP compliance in processes, and identify corrective and preventive actions.
Quality Culture Implementation: Foster a "Quality Culture" throughout the organization and facilitate the application of quality standards in all areas.
Collaboration: Collaborate with the QA team, other departments, and participate in investigations related to production deviations.
Change Control: Evaluate and approve change controls, ensuring the necessary actions are identified for approval.
Risk Assessment: Evaluate the impact of GMP compliance decisions on business operations, considering associated quality risks.
Training & Development: Maintain updated knowledge in quality assurance practices and provide training to new associates joining the department.
Health & Safety Compliance: Ensure compliance with safety and environmental regulations and participate in emergency plans when needed.
Client Complaints: Manage and monitor client complaints received and ensure proper resolution.

Qualifications

Education: University degree in health sciences (preferably pharmacy, biology, or similar).
Experience: At least 3 years of experience in quality assurance in the pharmaceutical industry, particularly in GMP environments.
Languages: Fluency in Spanish and a minimum B2 level in English.
Knowledge: Understanding of sterile environments is a plus.

Why Sandoz?

Sandoz is a leader in the generic and biosimilar medicines sector, helping over 500 million patients globally. With ongoing investments in development and production capabilities, Sandoz aims to shape the future of healthcare and make quality medicines more accessible to patients. Join us in our mission to support sustainable healthcare solutions while enjoying a flexible and collaborative working environment that promotes personal growth.

Commitment to Diversity & Inclusion

We are dedicated to building an inclusive work environment with diverse teams representing the communities we serve.

How to Apply

If you are interested in contributing to Sandoz's mission and meet the qualifications for this position, we encourage you to apply and join our team. If this role isn't a fit for your career goals but you'd like to stay connected, you can join the Sandoz Talentpool here.

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Quality Assurance Operations Technician - Temporal Apply

Job Description

Job Overview

Key Responsibilities

Qualifications

Why Sandoz?

Commitment to Diversity & Inclusion

How to Apply

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