QUALIFIED PERSON FOR BATCH RELEASE

Required qualifications:
• Bachelor of Sciences (BSc) degree in pharmacy or higher in a relevant scientific area (pharmacy) additional certified knowledge in GMP, QC or QA.
• At least 5 year relevant practical experience at one or more companies authorized to manufacture medicinal products in developing and implementing quality management systems.
• Language: English excellent.

Job Responsibilities:
• Responsible for the disposition and release of product manufactured and/or packaged on site or by 3rd Party Manufacturers & New Product Introduction Products.
• Ensure that each batch released has been produced and tested in accordance with the current EU GMP Directives and the relevant marketing authorization.
• Ensure that the Marketing Authorization and Manufacturing Authorization requirements for the medicinal product have been met for the batch concerned, and that the principles and guidelines of GMP as stated in Directive 2001183/EC amended by 2004/27/EC and 2003/94/EC and as interpreted in the EC guide to GMP have been followed.
• Ensure that the principal manufacturing and testing processes have been validated.
• Ensure that all the necessary quality control checks and tests have been performed and account taken of the manufacturing and packaging conditions including a review of batch records.
• Ensure that any changes or deviations in manufacturing, packaging or Quality Control have been notified in accordance with a well-defined reporting system before any product is released.
• Ensure that any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate to cover changes or deviations.
• Ensure all necessary manufacturing, packaging and associated documentation has been completed and endorsed by suitably authorized staff.
• Ensure regular audits, self-inspections and spot checks are being carried out by experienced staff, take actions necessary to maintain and extend their technical and professional competence and to ensure that they have a thorough understanding of any new product or process prior to conducting batch release of products.

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