Epicareer Might not Working Properly
Learn More

Quality Assurance Specialist

Salary undisclosed

Checking job availability...

Original
Simplified

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.

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.