Overview
- Review and approval of the bulk batch records and related documents.
- 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 and resolve all requirements/requests made by the customers (documentation request or information pertaining to product registration).
- Evaluate periodically bulk stock control to decide availability after holding time.
- Approve and/or reject batches of bulk products and intermediates in SAP system.
- Support to Customer requests based on QTA, Marketing Authorizations and/or Quality issues.
- Review and approved internal SOPs.
- Participation and support in internal audits, external audits and inspections according to the Annual Plan to assess the quality of the GMP system.
- Support to the qualified person and supervisor.
- Support and involvement on quality investigations.
- Suppport and involvement on Official GMP inspections and customer audits
- 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.
Responsibilities
Revision of master batch records and its validation/compliance on SAP system (BOM/Route). Manage GMP deviations relative to the process and site.
Review and approval manufactured batches.
Manage GMP deviations and OOS/OOT, previous to put them on the market.
Performed periodic stock control check; and manage of not conformities in accordance to internal procedures, GMPs rules, Authority and customers' requirements and quality policy
Qualifications
- Education: University Degree in Pharmacy, Chemistry, Biology or Sciences related to Health.
- Languages: Intermediate or high level of English and bilingual in Spanish.
- Experience (years/area): A minimum of 2 years' experience in similar position.
- Specific Knowledge: Quality Assurance expertise and extensive knowledge on revision of GMP documentation. Knowledge on SAP/R3 and MS Office
馃搶 qa technician
馃彚 Chemo
馃搷 Villaquilambre