Associate Quality Compliance
The Company
Our client is a global biotech company focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Role Description
As a Quality Associate Compliance you will be responsible for incorporate the principles of the Good Distribution Practices, into the EU regional supply chain network to ensure product quality is maintained, as well as incorporate the principles of the Falsified Medicines into the EU regional supply chain network to ensure product authenticity is maintained
Responsibilities
– Manage temperature assessment records.
– Manage minor and major deviation records and lead root cause analysis sessions.
– Support audits and inspections involving the EU supply chain, including audits and inspections.
– SME for document management control.
Requirements
– Bachelor’s degree or equivalent in Life Sciences.
– + 2 years’ experience in GMP / GDP compliance
– Knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
– Strong word processing, database and spreadsheet application skills and experience in Quality Management (track wise, Veeva) is a plus.
– Ability to apply risk-based approach, making decisions and escalating issues appropriately.
– Pro-active in proposing solutions and driving tasks to completion.
– Experience in audit / inspection support is a plus.
Other information
Are you interested? Feel free to contact me!
53675
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.