Supply Quality Specialist
Global Pharmaceutical Manufacturer seeks a Supply Quality Specialist.
About the role:
As the Supply Quality Specialist at, your role will be to ensure that products are manufactured and processed in accordance with company, corporate and international standards with respect to cGMP, product safety, quality and efficacy.
You will ensure that current industry standards are applied to the transfer of CP Pharmaceutical such as described in the ISPE Good Practice Guides for technology transfer and operations management.
You will also be required to ensure that the requirements of GAMP and equivalent standards are applied as appropriate with third party suppliers.
Skills and experience:
You will be experienced in the current industry standards for technology/product transfer as given in current regulations and guides such as the ISPE good practice guides. You will have experience in the extensive use of risk assessment procedures as described in Industry guidelines such as ICH Q9 in order to determine the type and extent of process required to achieve a satisfactory product / technology transfer and subsequent management of the contract manufacturing site being used. You will have the ability to work with concepts and practices outside the original area of academic qualification and apply them effectively in terms of GMP/QA matters.
You will have a degree (or equivalent) in a scientific discipline, with substantial experience in the pharmaceutical industry, preferably with experience within a quality function, including some auditing experience. Other key skills are a keen eye for detail and effective written and verbal communication skills.