– Manager must ensure that each batch has been produced and tested/checked in accordance with the directives of the Ministry of Health/Regulatory body as described in the marketing authorization.
– Responsible for approval of GMP documentation, implementation, review of Standard Operating Procedures and systems, records, forms, Regulatory documents, other documentation and retention of documents related to all department of facility.
– Responsible for approval of documentation like site master file, quality manual, validation master plan.
– Responsible for training and evaluation program to maintain individual skills keeping up to date with latest management concepts, including planning, procedures, tracking status, and providing training modules related to all department of facility.
– Responsible for self-inspection program including Plant Hygiene, Quality Management System, procedures, audit schedules, audit reports, observation follow-up and closure related to all departments of facility.
– Responsible for internal or external market complaint handling system, including procedures, investigations, and responses related to all department of facility.
– Responsible for managing compliance aspects of procurements, contract manufacturing and performs external vendor audits as needed and ensure that all suppliers used by the organization are selected, evaluated, revaluated and those records of this assessment are maintained.
– Responsible for readiness for regulatory inspections of facility, managing regulatory inspection responses and follow-up actions.
– Responsible for batch release, must certify in a register or equivalent document, as operations are carried out and before any release that each production batch satisfies the provisions of the United Arab Emirates GMP guide/ Other applicable regulatory bodies in accordance with manufacturing authorization.
– Responsible to approve the APQR, change control, CAPA, Deviation, 00S, Market complaints, records, risk assessment, validation protocols and reports etc.
– In case of absence responsibilities shall be transfer to experienced and trained staff to ensuring that the various checks and tests to be carried out.
– Proper operation of quality systems which include appropriate approvals, audits, self-inspections and spot checks that manufacturing, and testing has complied with relevant requirements.
– The Manager should be available at the manufacturing site for a sufficient proportion of the working time in order to be appraised of manufacturing conditions and for control of any delegation.
– Manager has duties not only to their employer but also to the Ministry of Health and its inspectorate and must ensure through line management that appropriate senior company executives are fully aware of any manufacturing and/or testing difficulties which may cast doubt on the release of batches.
– If there is any aspect of the QA system which is not in accordance with the Directives and Guidelines for Good Manufacturing Practice, then the Manager has a responsibility to bring this to the attention of Senior Management.
– Manager also have a duty to make representations to management, if necessary, in writing, whenever standards appear to be falling short of Good Practice.
– Manager also have a duty to make representations to management and authorized to represent in front of regulatory bodies.
– In cooperation with their employer, Manager will take actions necessary to maintain and extend their technical and professional competence when they are engaged at a time.