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ESO QA Manager

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Sandoz

6d ago

  • Job
    Full-time
    Senior Level
  • Madrid

AI generated summary

  • You need a degree in Microbiology/Biotechnology/Biochemistry, 5 years in Pharma QA, strong communication and problem-solving skills, GMP knowledge, and fluency in English.
  • You will lead supplier qualifications, manage quality agreements, handle deviations and complaints, ensure timely project deliverables, conduct audits, and review stability reports.

Requirements

  • University degree in Microbiology, Biotechnology, Biochemistry or equivalent.
  • Minimum 5 years of working experience in Pharmaceutical/Biopharmaceutical/API products. quality/quality assurance or operations.
  • Excellent communication and organizational skills.
  • Excellent skills in identifying issues and solving problems.
  • Excellent & detailed knowledge of GMP-regulations (EMA; FDA, CA, etc).
  • Fluent in English.
  • Knowledge of Microsoft Office.
  • Fluent in speaking/ writing in English.

Responsibilities

  • Lead External Suppliers Qualification process.
  • Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier and establishing good working relationships with clear communication and defined actions and goals.
  • Negotiation of Quality Assurance Agreements (QAA) with external partners.
  • Change and deviation management, complaint handling.
  • Escalate risks and issues, as well as propose mitigating actions.
  • Responsibility for ensuring timely achievement of project Quality deliverables.
  • Contribute to process simplification and QMS improvements.
  • Responsible for the conduct of internal and external audits of the quality system (approval of suppliers, contract suppliers and contract manufacture suppliers).
  • Stability reports and PQR’s review and approval.

FAQs

What are the key responsibilities of the ESO QA Manager?

The key responsibilities include leading the External Suppliers Qualification process, acting as the Single Point of Contact for quality-related activities, negotiating Quality Assurance Agreements, managing changes and deviations, handling complaints, escalating risks, ensuring timely achievement of project Quality deliverables, contributing to process simplification, and conducting internal and external audits of the quality system.

What qualifications are required for the ESO QA Manager position?

A university degree in Microbiology, Biotechnology, Biochemistry, or a related field is required, along with a minimum of 5 years of experience in Pharmaceutical/Biopharmaceutical/API products, quality assurance, or operations.

Is fluency in languages other than English required for this position?

Fluent English is required; however, knowledge of additional languages may be beneficial but is not specified as a requirement.

What skills are emphasized for the ESO QA Manager role?

Key skills include excellent communication and organizational abilities, problem-solving skills, detailed knowledge of GMP regulations, and familiarity with Microsoft Office.

What are the key performance indicators for this position?

KPI metrics include the number and severity of cGMP issues identified during audits, compliance of products according to agreed specifications, no out-of-stock incidents related to QA activities, fulfillment of training plans within the team, and KPIs as identified in the quality target letter.

What motivates Sandoz as a company in this sector?

Sandoz is motivated by the aim to provide low-cost, high-quality medicines to patients globally and to continuously improve development capabilities, production sites, and partnerships for better access to medicines.

What kind of work environment can I expect at Sandoz?

Sandoz fosters an open, collaborative culture that values diversity, encourages personal growth, and offers an agile and collegiate environment with impactful, flexible-hybrid careers.

Does Sandoz have a commitment to diversity and inclusion?

Yes, Sandoz is committed to building an outstanding, inclusive work environment and assembling diverse teams representative of the patients and communities they serve.

Can I apply if I have less than 5 years of experience in the field?

The position specifies a minimum of 5 years of relevant experience, so candidates with less experience may not meet the qualifications for this role.

Is training provided for the role?

The position includes a responsibility for ensuring training plans are met within the team, indicating that training and development are part of the environment at Sandoz.

Manufacturing & Electronics
Industry
10,001+
Employees

Mission & Purpose

Sandoz, a global leader in generic pharmaceuticals and biosimilars, is dedicated to improving access to high-quality, affordable medicines for patients worldwide. Their ultimate mission is to expand access to essential healthcare by developing and providing generic and biosimilar medicines that meet rigorous quality standards. Sandoz aims to make healthcare more accessible and affordable, ensuring that patients benefit from high-quality treatments and contributing to the overall improvement of global health outcomes. Their purpose is to enhance the quality of life for people by delivering cost-effective, innovative solutions in the pharmaceutical industry.