Quality Assurance Specialist (Temporary)

TR05 (FCRS = TR005) Sandoz İlaç Sanayi ve Ticaret A.Ş; Fatih; On-site; TRY 200,000 - 350,000; Full time

Job summary

Sandoz is seeking a Quality Assurance Specialist (Temporary) to ensure pharmaceutical products comply with GxP standards and local SOPs. The role supports product releases, CAPA, deviations, and regulatory interactions across the site.

Ideal candidates have a BA in a related field and at least 2 years of QA experience in pharma, with strong analytical skills and the ability to drive continuous improvement in a dynamic environment.

Qualifications

• BA 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.

Responsibilities

• 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).

Skills

QA

GxP

Deviation management

CAPA

Batch documentation

Regulatory knowledge

Cross-functional collaboration

Education

BA in Chemistry, Chemical Engineering, Pharmacy or related fields

Job description

Job Description Summary

We are currently looking for a Quality Assurance Specialist (Temporary) This is a temporary, fixed-term role for 12 months. 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.

Job Description

We are currently looking for a Quality Assurance Specialist (Temporary) This is a temporary, fixed-term role for 12 months. 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 Manual, Quality Agreements, GxP requirements and local SOPs. In this temporary (12‑month) role, you will play a key part in safeguarding product quality, compliance, and continuous improvement across the site.

Your Key Responsibilities

• 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

Minimum Requirements:

• BA 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

Our Purpose

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!