The QA Specialist is responsible for supporting operation of core Quality Systems used in the Drug Substance Manufacture Facility and providing QA support to both manufacture operations for drug substance and to laboratory operations for drug substance and drug product testing. Activities will include Maintenance of Quality Systems including Training, Change Control, Deviations, CAPA, and Supplier qualification. QA review and assessment of QC data including investigations, out of specification and unplanned events will form a key part of this role.
The role reports to the QA Lead.
Roles and Responsibilities:
Oversee investigations, out of specification and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required
Oversee change control management process ensuring impact of proposed changes are adequately assessed how the implementation is managed
Assist with compilation and analysis of data associated with performance of the Quality System (e.g. Management Reviews)
Responsible for the management of GMP training and to foster a quality led culture across the new site
To conduct supplier audits, Internal audits and co-ordinate regulatory audits
Assist with preparation and execution of back room activities for Health Authority Inspections
Perform batch review and approval of release documentation
To support the onsite development function as required
To manage the implementation of process improvements in line with the QMS
Ability to exercise judgment with defined procedures and practices to determine appropriate action.
Accountable for completing activities within required timelines
Proactively highlight any issues around compliance.
Willingly accepts challenging assignments
Qualifications and Education Requirements:
Bachelors Degree in scientific discipline preferred plus 3+ years experience working as a QA Specialist or Quality System specialist in Pharmaceutical Manufacture Facility. Experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems required.
Lead Auditor Qualified an advantage.
Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.
Must be able to function effectively in a teamwork environment.
The individual must demonstrate an ability to work independently.
Thorough, diligent, good attention to detail.
Collaborator with strong levels of engagement with individuals and team.
High level of delivery and work completion.
Strong organizational skills.
Associated topics: bacteria, biomedical, biopharmaceutical, dietetic, disease, food, immuno oncology, immunohematology, kinesiology, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.