What are the responsibilities and job description for the Quality Assurance Manager Position position at Integrated Resources, Inc ( IRI )?
Integrated Resources, Inc (IRI) is a renowned organization in the pharmaceutical industry. We are seeking an experienced Quality Assurance Manager to lead our quality initiatives.
The ideal candidate will have strong working knowledge of Quality System Regulations and experience leading CAPA activities. They will be responsible for quality review of documents associated with protocols, functional specs, detail design specs, site acceptance tests, and data packs. Additionally, they will investigate deviations and serve as the final approver on such documents.
A Bachelor's Degree/Undergraduate Degree in engineering or technical discipline is required. A Master's Degree is preferred. The successful candidate will have experience in the pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment, with a background in life sciences being a plus.
Key Responsibilities:
- Quality review and approval of critical documents
- Leadership of CAPA activities
- Investigation and resolution of deviations
- Collaboration with cross-functional teams
Requirements:
- 6-9 years of experience in quality assurance
- Experience in bulk formulation and aseptic filling is preferred
- Strong communication and interpersonal skills
- Ability to work under pressure and meet deadlines
