Job Descriptions

Job Purpose:

To verify and document that batches are within specification and compliant to MGS and customer specification prior to release and shipment.

Job Responsibilities:

• Timely generation and approval of all ‘Certificates of Analysis’ (COAs) and ‘Certificates of Conformity’ (COCs) for batches produced at MGS

• Review lot history to ensure that batches have been visually inspected, measured to the necessary ‘Acceptance Quality Limit’ (AQL) requirement and all relevant paperwork is completed and compliant. Ensure batches are not shipped from QAHOLD or before any non-conformance reports are complete.

• Timely data analysis of in-process measurements to ensure that products are being produced as per specification, sampled to the required AQL, and escalates issues as required.

• Monitor all testing/inspection activities and results to ensure that they are in place to support the release of batches as per MGS and customer buy specification; reports any issues in a timely manner.

• Ensure timely and effective testing of samples in accordance with schedules and policies, procedures and guidelines.

• Assist in the resolution of shipment issues and ‘Out of Specification’ (OOS) investigations which may arise during testing.

• Support supply chain, production and warehousing in the coordination, scheduling and release of shipments.

• Complete final inspections for shipments as required.

• Draft and conduct training as required in relation to Batch Release procedures, documentation, etc.

• Focus on batch release process improvements, troubleshooting issues and complaints.

• Conduct audits and engage in auditing activities as required.

• Provide quality reports and update data logs as required, e.g., Screening Report Lot.

• Track and report GDP compliance performance for each shift

• Data gathering and metrics generation

• Ensure continuous feedback to production and QA Lead on issues and problems that may arise.

• Be responsible for the maintenance and storage, including the archiving of Batch Release Documentation packages

• Support the Quality Engineer and Project team with New Product Introduction (NPI) including the set up of COA templates

The above list of duties and responsibilities is not exhaustive, and the role holder may be required to carry out other duties which may reasonably be assigned by management.

The Ideal Candidate:

• Will have experience with an ERP system and a basic knowledge of statistics and the systems used to metrics (e.g. excel, Jmp, minitab)  

• Will have a good quality mindset with an understanding of GMP and GDP

• Possess excellent interpersonal, teamwork, IT, verbal and written communication skills.

• Have an understanding of QMS principles (preferably ISO13485, ISO14644 and/or ISO14001)

• Have information management, analytical and numerical skills with a high level of attention to detail.

• Be a team player and capable of working independently and on own initiative.

• Be well-organised, highly self-motivated and capable of multi-tasking in a fast-paced, pressurised environment

Skills

• Interpersonal Skills
• Excellent written and verbal communication skills

Experience

• 2+ years