Overview:Prepare and review release specifications, shelf life requirements and customer requests; revision of master batch records and its validation/compliance on SAP system (BOM/Route); manage GMP deviations relative to the site; review and approval manufactured and packaged batches and related analytical data, including OOS if any, previous to put them on the market; revision and sign the certificate of analysis; periodic stock control check; manage of not conformities form for packaging materials according to European standards and quality policy. All this taking into account the safety regulations indicated by the company and the use of personal protective equipment provided depending on the risks of each operation.
Responsibilities:
Revision and approval of the API, raw materials, packaging components, bulk and finish product release specifications.
Review and approval of the bulk and packaged batch records and related documents.
Review and approval of the analytical data related to the industrial products and/or components according to the internal SOPs, including OOS, OOT and deviations.
Issue, review and approve documents and sign the certificates of analysis of batches manufactured for release or for regulatory purposes on different countries to be marketed.
Issue and approve certificate of analysis related to raw materials.
Approve and/or reject batches of product (bulk and finished), raw materials and packaging materials in SAP system.
Monitoring deviations/OOS/OOT reports raised on batches for approval.
Review, maintain and approve all master batch records and its status on SAP system according to the marketing authorization.
Evaluate all requirements/requests made by the client (documentation request or information pertaining to product registration) to be solved.
Evaluate periodically bulk and packaging stock control to decide availability after holding time.
Support to Customer requests based on QTA, MA and/or Quality issues.
Management of complaints sent to the suppliers related to received batches.
Review and approve stability protocols.
Review and approved internal SOPs.
Support on official quality inspections and customer audits.
Perform internal shelf inspections and external audits to third parties and/or suppliers.
Support to the qualified person.
Support on quality investigations.
Management of retention samples.
Management of GMP documentations and related archive.
Train the new incorporations in the specific activities and functions of the position in which you are an expert.
Qualifications:
Education: University Degree in Pharmacy, Chemistry, Biology or Sciences related to Health.
Languages: High level of English and bilingual in Spanish.
Experience (years/area): A minimum of 5 years' experience in similar position for a senior position.
Specific Knowledge: Quality Assurance expertise and extensive knowledge on revision of GMP documentation. Knowledge on SAP/R3 and MS Office system.
Personal skills: Good communication skills, proactivity, good working under pressure, team working, problem-solving, good organizational skills and persistent.
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