Quality - R&D

Key responsibilities

• Serves as a dedicated quality representative on project teams responsible for design and development of drug products.

• Serves as the primary quality assurance contact for internal and external business partners and contractors.

• Provides tactical insights into regulatory compliance strategies.

• Focuses on technical issues relative to interpretation of policies, compliance and current industry standards.

Must-have experience / knowledge

• Minimal a Bachelor education.

• At least 10 years relevant work experience in QA.

• Up to date GMP, FDA, IGJ knowledge and experience.

• Validation, qualification and automation experience.

Non-Technical profile requirements

• Some flexibility in working hours is required;

• Must be able to work on multiple simultaneous tasks with limited supervision;

• Quick learner, motivated self-starter;

• Excellent customer service, interpersonal, communication and team collaboration skills;

• Able to follow change management for internal guidelines.

Language proficiencies

-English spoken and written is a must.

Extra info

The selected candidate will support the QA organization for the projects you get assigned to. From equipment introduction and qualification to support for new product introduction. You will be working on several projects in parallel.

You need to be productive asap when hired. Preferably full time and directly available. Initial hiring period is 6 months. With the intent to extend based upon available projects.