What are the responsibilities and job description for the Quality Assurance Specialist position at Aspire Pharmaceuticals?
SUMMARY:
This position is primarily responsible for coordinating and directing quality assurance programs and reviewing, preparing/maintaining SOPs, calibration, and other controlled documents to ensure accuracy, completeness, and adherence to established standards by performing the following duties.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Ensures compliance with cGMP, Company SOPs and FDA requirements during all phases of operations.
- Sampling and disposition of Packaging Materials and Packaging Components as per standard operating procedures
- To support raw material sampling as needed.
- Issuance of Batch Manufacturing records and Batch Packaging Records as per requirements.
- Disposition of raw materials and finished products as per standard operating procedures.
- Prepares and maintains vendor qualification reports and its requalification reports.
- Prepares, maintains and issues raw material specifications.
- Prepares and maintains analytical specifications for raw material testing and retesting.
- Organizes and ensures accurate and reliable filing systems for all paper-based GMP Documents.
- Review of executed batch manufacturing and packaging records.
- Prepare shipment for samples as per the requirements of customers.
- Completes quality assurance operational requirements by scheduling or co-ordination
- Prepares and maintains all Quality Systems, including CAPA, Complaint Handling, Deviations, Nonconforming Product, and Internal Auditing to comply with regulatory requirements.
- Prepare and maintain master manufacturing record, COA, SDS, finished product /packaged product specification.
- Preparation of Annual Product Quality Review
- To ensure appropriate storage, issuance, periodic visual inspection and destruction of retain samples.
- Other duties as assigned by management.
EDUCATIONAL QUALIFICATION:
A four-year college degree or master’s degree, zero to two years of related experience and/or training, or equivalent combination of education and experience.
