Description
Leading supplier of generic pharmaceutical products are currently seeking a Quality Control Specialist to join their site in Cork. This global supplier of generics are looking to expand their operations in Cork.As the Quality Control Specialist you will be primary responsible for Quality Control testing in launching and routine testing of finished product and compliance with cGMP's. Support the regulatory requirements of finished product, supplier management and investigation of product issues.
Duties:
Ensures compliance with cGMP's, Environmental, Health & Safety regulations.
Executes all Quality Control activities to ensure timely & compliant launch of finished products.
Manages & executes all routine Quality Control testing to ensure timely & compliant release of finished products.
Executes the finished product Exception Program.
Supports regulatory requirements of finished products
Supports the timely receipt and release of finished products.
Prepares and executes method development, validation plans and protocols for the laboratory.
Supports the document control system & record retention.
Execute and organise the calibration and maintenance of laboratory equipment.
Executes and supports batch record reviews to ensure timely release of finished product according to schedule.
Develops and implements Standard Operating Procedures
Requirements:
BSc in a scientific discipline
Minimum of 3 years in a cGMP facility in a Quality Control role.
Experience in HPLC is required.
Salary Range 35-45K DOE with benefits