The Quality Assurance Specialist is responsible for maintenance of the Almac Pharma Services quality management system, batch record review and ensuring that operations are conducted in accordance with current Good Manufacturing Practice.
Responsibilities include, but are not limited to:
Actively assist all departments in the generation of quality system documentation such as deviation reports and change control.
Compile and report on quality system metrics to identify trends and facilitate management review.
Review and approve master batch records, executed production batch records and associated supporting documentation.
Carry out internal audits to ensure GMP compliance.
Identify and implement SOP revision requirements.
Assist in the preparation of Annual Product Reviews.
Coordinate the conduction of investigations and corrections for issues found during the batch record review process.
Provide regular updates to the QA Team Leader regarding work allocation.
Notify the QA Team Leader of any issues which may impact the client (quality issues, batch record completion deadlines).
Notify the QA Team Leader of any issues which are, or may become, a GMP compliance issue.
Interface with all levels of Almac Pharma Services personnel in resolving issues.
Perform other duties required of the QA team as and when required.
HS Diploma required; Bachelors Degree highly preferred
Minimum of 2 years relevant experience in a pharmaceutical quality assurance/control environment
Experience of GMP document review, Quality Management System maintenance, quality auditing preferred
Must be able to lift up to 10 lbs
Ability to work with teams and independently, good interpersonal skills
Good communication skills: verbal and written, good computer and organization skills, detail oriented
Problem analysis and solution skills
Strong customer service experience required
ALMAC Clinical Services - 19 months ago