Manager, Quality Assurance - GxP (GCP Auditing) Remote
Axsome Therapeutics IncSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalIndustries
Requirements
Candidates must possess a graduate qualification or BTec/equivalent in Pharmacy or a scientific subject, along with a minimum of three years of relevant experience in a GMP environment. Expertise in Quality Assurance, Production, Validation, and Microbiology is required, along with a strong understanding of aseptic techniques and EU GMP standards. Strategic thinking, good interpersonal skills, and the ability to manage and motivate a team are also essential.
Responsibilities
The QA Supervisor will manage the QA Team, including development and performance reviews, ensuring QA procedures are up-to-date and compliant with deadlines, assisting in MHRA inspector visits, managing equipment calibration, overseeing recruitment and training, authorizing documents, and maintaining QA databases. They will also ensure aseptic suites meet high standards, perform reviews of NCRs, Change Controls, and Validation documentation, and communicate effectively both verbally and in writing while working with minimal supervision and maintaining a high degree of attention to detail.
Skills
GMP
Quality Assurance
Production
Validation
Microbiology
Aseptic Techniques
EU GMP standards
NCRs
Change Controls
Validation documentation
Baxter International
Provides essential medical products and services
About Baxter International
Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.
Key Metrics
Deerfield, IllinoisHeadquarters
1931Year Founded
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees