Quality Assurance Manager

SUN PHARMA; Leverkusen; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global pharmaceutical company in Leverkusen is seeking a Quality Assurance Manager to oversee the local Quality Management System, ensure GMP/GDP compliance, and act as a key contact for quality-related issues. The ideal candidate should have strong experience in pharmaceutical quality management, excellent organizational skills, and a proactive mentality. This role offers the chance to impact patient safety while working collaboratively across Europe.

Qualifikationen

• Solid experience in pharmaceutical quality management (GMP/GDP).
• Strong understanding of manufacturing processes and analytical testing methods.
• Team player with a proactive and solution-oriented mindset.

Aufgaben

• Implement and continuously improve the local Quality Management System.
• Act as contact person for product-related quality issues.
• Ensure effective handling of product quality complaints and recalls.

Kenntnisse

Experience in pharmaceutical quality management

Knowledge of quality systems (GMP, GDP, ISO 9001)

Strong communication skills

Excellent organizational skills

Team player

Ausbildung

License to practice as a pharmacist

Jobbeschreibung

Quality Assurance Manager (2-year contract)

Who We Are

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$6 billion. Supported by more than 40 manufacturing facilities and more than 40.000 employees around the globe, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.

Over the last two decades, Sun Pharma has established itself as a leading player in the generics market, and are rapidly ramping up their presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Values

At Sun Pharma our core values—Humility, Integrity, Passion, and Innovation—are part of our unique culture, known as Sunology.

We are empowering our employees to create their “Own Sunshine”. We believe in being Better Everyday by investing on lifelong learning, Taking Charge by owning our impact, and Thriving Together in a workplace where collaboration is encouraged. We are committed to being an inclusive and equitable employer, valuing diverse perspectives and creating an environment where all individuals feel respected, heard, and inspired to bring their best selves to work.

About the Role

As Quality Assurance Manager, you will be the central contact and expert for the local Quality Management System (QMS) in Germany. You will act as an internal consultant on all quality-related issues, ensure compliance with global and local GMP/GDP requirements, and represent Sun Pharma with regulatory authorities. This role offers a high level of responsibility and visibility, both locally and within our regional and global quality organization.

Key Responsibilities

• Implement, maintain, and continuously improve the local Quality Management System in line with global standards and local legislation.
• Act as contact person for product-related quality issues with local management, employees, customers, and GMP/GDP authorities.
• As part of the Local Recall Board, ensure effective handling of product quality complaints, recalls, and significant quality events by conducting investigations and root cause analysis.
• Support wholesale representatives in fulfilling their responsibilities with regards to the “Ordinance on Wholesale and Drug Brokerage”.
• Oversee quality training programs, including GDP refresher training for employees.
• Support business development and new product launches with quality expertise.
• Collaborate with European and corporate quality teams on supplier qualification and quality agreements.
• Provide pharmaceutical expertise for quality operations and day-to-day issues.

Requirements

• License to practice as a pharmacist (non mandatory).
• Solid experience in pharmaceutical quality management (GMP/GDP).
• Knowledge of quality systems according to GMP, GDP, ICH Q10 and ISO 9001.
• Strong understanding of manufacturing processes and analytical testing methods.
• Excellent organisational and time management skills.
• Strong communication and stakeholder management abilities.
• Team player with a proactive and solution-oriented mindset.
• Previous training as a pharmaceutical technical assistant is considered a plus.

Why Join Us?

At Sun Pharma, you will have the opportunity to make a direct impact on patient safety and product quality while working in an international environment. You’ll collaborate with colleagues across Europe and globally, gain exposure to diverse stakeholders, and contribute to our mission of improving access to high-quality medicines.