Senior QA Manager

*Purpose:*   A large pharmaceutical company developing, manufacturing and internationally marketing well-proven and innovative pharmaceuticals is seeking a *Senior QA Manager *who will to ensure that quality systems are in compliance with local regulations and are aligned to quality directives, ensure that pharmaceutical quality system elements are managed as per approved directives, policies and standard operating procedures   *Key Job Outputs:*   *General* * Undertake product releases to the market * Manage the quality management systems * Assist the head of quality assurance in the preparation of the annual site quality review report * Identify quality risks and mitigation of those risks * Conduct oversight of batch release and placement of products on the market * Manage approvals or rejections of starting material, packaging materials, intermediates, bulk and finished products * handle and manage events and non-conformities as well as corrective and preventive action * Conduct logging, reviewing of changes and correct implementation of change control systems * Manage pharmaceutical quality system elements such as deviations and quality complaints * Ensure that periodic quality reviews are undertaken on an annual basis * Ensure that ongoing stability is undertaken at contract manufacturing * Manage organisation in line with regulatory requirements * Review standard operating procedures, batch manufacturing records, batch packaging records and finished product * Manage specifications, process validation protocols and reports * Negotiate and facilitate the development and signoff of technical quality agreements * Carry out quality risk assessment and compile a risk management plan * Ensure and supervise the correct destruction of damaged, returned and expired goods and to retain the necessary records * Ensure that the correct quantity and storage of retention samples as per relevant requirements * Prepare and execute audits internally and externally in collaboration with corporate quality assurance * Assist during the preparation of health authorities, principals and corporate quality assurance inspections * Assist the head of quality assurance during the quality review board meetings including the regular reviews of operations, process, performance and monitoring of product quality * Become responsible for continuous improvement of product quality and of the quality system, through monitoring of the requisite KPI * Ensure that the appropriate escalation of quality risk and issues are identified and communicated to the head of quality assurance as per escalation and crisis management directive * Assume the responsibility to suspend operations if not in conformance with GXP, company standards, procedures or product specifications in the absence of the head of QA * Assist in initiating field alerts and product recalls in collaboration with the head of QA, responsible pharmacist, regi