Quality Assurance Specialist (Temporary)

Posted 9 Days Ago
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İstanbul, Fatih, İstanbul, TUR
In-Office
Junior
Biotech • Pharmaceutical
The Role
Ensure product quality and compliance with GxP standards in pharmaceutical production, documenting processes and managing quality issues and training.
Summary Generated by Built In

Job Description Summary

-Assurance that the product quality conforms with specifications and that production activity is compliant with Sandoz quality policy and GxP requirements. Ensure that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP  

Job Description

This is a temporary, fixed-term role for 18 months.

Job Description

As part of the Quality Assurance team, you will ensure that all pharmaceutical products are manufactured, handled, stored, and released in accordance with Sandoz Quality standards and GxP requirements. In this temporary (18‑month) role, you will play a key part in safeguarding product quality, compliance, and continuous improvement across the site.

Your Key Responsibilities

Your responsibilities include, but are not limited to:

  • Ensuring all manufacturing, handling and distribution activities comply with Sandoz Quality Manual, Quality Agreements, GxP requirements and local SOPs.

  • Preparing, reviewing and archiving batch documentation according to regulatory and internal guidelines.

  • Conducting GxP monitoring, managing QA investigations, and following up on corrective and preventive actions (CAPA).

  • Managing and approving deviations, complaints, recalls, stability failures and other critical quality issues.

  • Leading change control processes and ensuring timely implementation and closure.

  • Planning and executing self‑inspections and ensuring required actions are taken promptly.

  • Delivering GxP training programs for employees and ensuring annual training plans are implemented.

  • Supporting product releases, launches, and interactions with regulatory authorities and internal/external stakeholders.

KPI: Timely and compliant execution of QA processes (deviations, CAPA, batch documentation, training, self‑inspections).

What you’ll bring to the role

Essential Requirements

  • Bachelor’s degree in Chemistry, Chemical Engineering, Pharmacy or related fields.

  • Minimum 2 years of QA experience in the pharmaceutical industry.

  • Strong understanding of GxP, Quality Systems and regulatory expectations.

  • Experience in deviation management, change control and product release processes.

  • Ability to collaborate effectively across functions and with external partners.

  • Strong analytical mindset with attention to detail.

  • Ability to manage ambiguity and drive continuous improvement.

  • Languages: English (required)

Desirable Requirements

  • Experience working with cross-functional or international QA teams.

  • Exposure to regulatory inspections or audits.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! 

Join us, help us make healthcare fairer and faster.

Skills Desired

Change Control, Continued Learning, Dealing With Ambiguity, Guideline, Product Release, Qa (Quality Assurance), Quality Management, Regulation, Risk Management, Self-Awareness, Technological Expertise

Top Skills

Change Control
Gxp
Quality Systems
Regulatory Compliance
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The Company
HQ: Basel
17,135 Employees

What We Do

Sandoz is the global leader in generic and biosimilar medicines. ​ ​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​ We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

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