BTG Specialty Pharmaceuticals provides rescue medicines typically used in emergency rooms and intensive care units to treat patients for whom there are limited treatment options. We are dedicated to the development, manufacture, and commercialization of quality medicines that make a real difference to patients and their families. Our current portfolio of antidotes counteract certain snake venoms and the toxicity associated with some heart and cancer medications. BTG Specialty Pharmaceuticals is a division of Boston Scientific. To learn more, visit:
To support the effective functioning of the Quality Management System and provide assistance to the Quality Assurance Department as required.
Coordinating and maintaining all activities required for the disposition of finished product by Qualified Persons.
Responsible for the compliant maintenance of the Quality Management System including review of QMS actions, QE’s, CAPA, CC’s etc.
Review, check and approve completed batch and ancillary quality documentation to ensure compliance with GXP and assist the disposition of finished product by Qualified Persons.
Liaise with external contractors and BTG personnel regarding the release of finished product.
Prepare any required corrective and preventative actions related to the release of finished product.
Generate Certificates of Analysis and statements of GMP Compliance.
QA review of Validation documentation
Participation in inspection readiness activities and the internal audit program
To support the release, shipment, quarantine and rejection procedures for drug substance and finished product.
To support the release, shipment, quarantine and rejection procedures for drug substance within and finished product.
Support the product recall procedure.
Support release of cleaning, solution, bulk immunogens and Drug Substance within production timelines.
To support customer enquiries and complaints procedure.
To ensure key quality performance indicators are prepared and trended for the monthly report, management review and annual product reviews.
Take opportunity as available to develop within areas of the QA Lead role and deputise for the QA Lead role as appropriate.
Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BTG values.
Carry out other reasonable tasks as required by the Line Manager.
Education and Experience
Educated to degree level or equivalent in appropriate scientific discipline such as Chemistry, Biochemistry, Microbiology or life sciences (An applicable level of related industry experience in lieu of a degree will be considered)
Previous experience of working within the pharmaceutical industry is desirable, preferably with experience in GMP and Quality Assurance roles
Computer literacy (including word, power point, excel, databases)
Experience of working with a regulated industry
Skills and Attributes
Competent and highly organise individual who has a keen eye for detail
Creative thinker able to solve problems, question the status quo and consider innovative solutions to complex issues
Ability to prioritise and execute tasks in a high pressure environment
strong written and oral communication skills
Excellent organisational skills and the ability to work to tight deadlines within a team environment
Self motivated and directed
Confident and with an ability to work with employees at all levels of seniority
Boston Scientific is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.