Senior QC Associate with Lab testing experience

Senior QC Associate with Lab testing experience

Job Purpose and Scope:

The primary objective of this position is to facilitate Sydney based complementary manufacturer in their relevant processes and systems to comply with local regulatory requirements and relevant authority in Australia.  

Core Job Responsibilities:

List the primary tasks or activities this job performs

• Sampling of raw material and onsite laboratory testing. Review all test results and store all documentation. 

• Analytical method development for the raw material & finished products

• Issue and maintain the GIN register. Track and maintain up to date GIN register

• Perform packaging material inspection and maintain and update packaging documentation

• Maintain and update the batch manufacturing records and batch packaging records

• Performs in-process checks on all production and packaging lines 

• Review and record environmental monitoring data such as temperature, humidity

• Performs sampling of the purified water system

• Ensure GMP standards are adhered to by all production staff

• Meet the requirements to Code of GMP by complying with all relevant Quality policies and procedures to ensure the Quality objectives of the business are met.

• Establish and maintain specifications and standards for control of raw material; packaging and finished products.

• Manage/coordinate company quality system.

• Coordinate / perform / assist with product registration process include research therapeutic functions of new products and prepare and submit ARTG listing application.

• Support other departments on technical and quality issues especially Sales / Production / Operations departments.

• Maintain existing licenses and acquire required licenses/certificate as needed.

• Maintain the company MVP programs include carry out IQ/OQ/PQ, process validation and cleaning validations. 

• Assist QA manager throughout the day-to-day function as required

Knowledge / Education Required:

Minimum Bachelor of Science or Engineer or equivalent. 

Experience Required:

Hand on experience required in QC level to perform this job. 

Must have been a quality control experience in pharma/complementary industry with minimum 1 years experience.

Knowledge of Australian Health Authority TGA regulations a must with understanding of basic principles in HACCP preferable. 

Preference will be provided to candidates with previous experience in a complementary manufacturing facility.