Plant Manager

Job Description : PLANT MANAGER MEXICO Company focused on the production of accessories for the food and pharmaceutical industry requires a responsible plant manager for health and production with regulatory knowledge (ISO9001 and ExcI pact, AELOR) and certifications focused on process quality. The position requires someone strong in the financial management of the operation with strong interpersonal and leadership skills. Must have career as chemical engineer, pharma or whatever. The Plant Manager will be responsible for the pharmaceutical and food plant. Plants specialize in grinding additives for each of these industries. The objective of this position is: Manage maintenance areas, validations, calibrations, stability s. physicochemical and microbiology laboratories as well as stability and quality assurance laboratories. Release raw materials, packaging materials and finished product. Manage, supervise and ensure that the EMS is applied, including training programs, supplier approval, internal and external audit program in accordance with current pharmaceutical legislation, safety legislation and in accordance with ISO-9001, FSSC- 22000 and Excipact. Manage the CAPA system managing any deviation that has been attributed to the quality of the product. Attend internal and external audits of clients and regulatory entities. Manage the activities of the production unit of the Appenmix and Easycoat plants. Manage the quality unit of Belenus Farma The responsibilities of the position will be Guarantee that the comprehensive Quality Management System is applied and maintained in accordance with current pharmaceutical and safety legislation Ensure that annual and ongoing training programs are maintained Manages the CAPA system ensuring customer complaints are addressed. Approve all subcontracted activities that may have an impact on the quality of the product. Manage and execute the internal and external audit program. Receive audits from regulatory authorities and clients Decide and release the finished product of the excipient mixture plants. Ensure that all laboratory, plant, warehouse and maintenance activities that have an impact on product quality are carried out in accordance with GMP, GLP and BPD. Ensure that suppliers of raw materials and supplies are approved. Authorize all the documents of the Integrated QMS that guarantee the quality and safety of the product and ensure that they comply with current health and safety legislation as well as with the IS0 -9C00, FSSC-22000 and Excipact Standards. Ensure that critical systems and laboratory and plant equipment remain within their validated status in accordance with NOM-059. Ensure that measuring instruments are calibrated. Ensure that the production unit of the pharmaceutical and food excipient and additive mixture plants comply with the regulation that applies to each business unit NOM-059, FSSC-22000, ISO-9001· and ExcI pact. Ensure that the production unit complies with the MANUFACTURING programs on time and in accordance with the established manufacturing program. Prepare maintenance and operation budgets for the Atitalaquia site and report them to senior management. Request the necessary resources to maintain the optimal operation of the entire Atitalaquia site. Manage and coordinate the release of CEDI materials, from the pharmaceutical, food and ICS business units.

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