Job Summary

The Pharma Solutions business will be taking on its next chapter of growth as a trusted partner for the pharmaceutical industry with the announcement to sell Pharma Solutions to Roquette. This move will position Pharma Solutions to expand its industry leadership through continued investment in innovation to meet the evolving needs of pharmaceutical manufacturers and developers worldwide. The sale is presently expected to close in the first half of 2025, pending regulatory approvals and other closing conditions. The Pharma Solutions business unit will remain a part of IFF until close and, at such time, it will transition to Roquette. In applying for this position, you acknowledge your awareness that the position is a part of the Pharma Solutions business unit and has been identified to transition to Roquette.

The Quality Assurance Specialist will be part of the German Quality team in the Pharma Solutions (PhS) Business Unit. The role will be based at ourStade or Bomlitz site where we produce high quality products for pharmaceutical excipients and furthermore for a broad range of food applications.

As Quality Assurance Specialist you are responsible for the management of quality systems to ensure compliance with quality and regulatory requirements and corporate quality standards. The Quality Assurance Specialist II works closely with all facility personnel to ensure excellent quality performance and full compliance with cGMP and Food Safety requirements.

Your Responsibilities:

Identify and participate in internal quality improvement initiatives, perform gap analyses and risk assessments, develop and implement improvements, create and revise relevant SOPs.
Responsible for enforcing current Good Manufacturing Practices and other quality-related policies to meet product quality standards.
Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.
Make proactive recommendations and offering/presenting solutions to the Quality Systems & Regulatory Compliance Department Management to improve quality and work efficiency.
Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support in order to meet product quality standards.
Participate in all regulatory, third party and customer audits and inspections, and corrective action response.
Assist in maintaining Food Safety and Food Defense programs that define requirements to maintain compliance with Food safety standards.
Internal Auditing: Work with site operations team to develop and execute risk-based audit plans to mitigate quality risk.
Oversee and coordinate the site’s 3rd party Quality audit programs.
Ensure GMP training is effective in sharing GMP know-how needed to achieve best in class quality operations.
Work with the site Food Safety committee to accomplish Food Safety objectives and to maintain continued compliance with all requirements. Provide coaching at all levels of the organization.
Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.
Act as QA reviewer for investigations, deviations, complaints, and CAPAs as designated by QA Management.
Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.
Follow up with implemented programs (GMPs, Good Hygiene Practices, HACCP, Allergen Control, Cleaning and Sanitation, Pest Control, Equipment Calibration, Organic Certification, etc.) to ensure compliance by all employees and other personnel in the manufacturing facility.
Assist in the coordination with lab management of testing results involving finished products, raw materials, and packaging components and the appropriate release and hold programs associated with these materials.

Your Qualifications:

Bachelor’s Degree in Life Sciences, Pharmacy, or Engineering with least 3-5 years of work experience in quality assurance in dietary supplements, food/beverage, pharmaceutical or cosmetic industry or an Associate degree with at least 5 years of relevant experience in Quality Assurance.
A good knowledge of Current Good Manufacturing Practices, preferably 21CFR Part 111, 211, IPEC GMP, ICH Q7, FSSC 2200, and food safety.
Good understanding of quality testing within the food and beverage, pharmaceutical or cosmetic industry to include analytical and/or microbiological analysis. Must possess a basic understanding of chemical and microbiological analysis and basic math.
Ability to work under pressure and make effective decisions.
Experience with Root Cause Analysis tools.
Skill in organization and prioritization, and attention to details.
Strong team player and leader with the ability to work across multiple functions and disciplines.
Must be able to effectively communicate ideas (verbally and in writing), be a self-starter and handle difficult reporting situations.
SAP experience preferred.
Very good command of German and English

We are looking forward your application!

We are a global leader in taste, scent, and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.

Visit IFF.com/careers/workplace-diversity-and-inclusion to learn more

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Quality Assurance Specialist