What are the responsibilities and job description for the Quality Manager position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Roles & Responsibilities:
- Strong working knowledge of Quality System Regulations.
- Experience leading CAPA (Corrective and Preventive Action) activities.
- Quality review for documents associate with protocols, functional spec, detail design specs, site acceptance test, data packs.
- Also, investigate deviations and will be final approver on such documents.
- Ability to work on strict deadlines.
- Ability to interface with cross-functional teams.
- Detail oriented.
- Ability to handle multiple projects concurrently.
- Well-developed communication skills, both verbal and written.
- Bachelor's Degree/Undergraduate Degree in engineering or technical discipline. Master’s degree preferred.
- 10 Years Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.
- Experience in Bulk Formulation and Aseptic Filling.
Additional Information
All your information will be kept confidential according to EEO guidelines.