Validation Manager (East London) - East London
Aspen Pharma Group
Overview Control and manage validation function to ensure equipment is validated in compliance with GMP/ regulatory requirements Provide technical support, process control and process improvement activities to support validation activities Manage and guide the unit through team leaders Performance management of direct reports and unit Responsibilities Planning and Unit Management Provide technical and operational input during the drafting of processes, policies and procedures for unit Monitor implementation of operational plan by team Manage operational budget of the unit Ensure availability and optimal allocation of resources to achieve operational objectives Perform human resource functions for optimal management of unit Validation Ensure validation plans, SOPs and protocols are compiled and implemented to ensure continued compliance at all times Manage validation activities within value stream validation programme according to validation plan/ schedule Evaluate results from executed validation protocols Ensure validation protocols and validation reports for new equipment / systems are documented and compiled Develop and implement re-validation plans Maintain and audit compliant state of validation department Review validation training requirements and implement training where necessary Qualification Manage qualification activities with QC and Production Review and approve relevant qualification protocols as per SOP Manage change controls to ensure compliant status of affected equipment is not compromised Ensure documents and procedures to operate and maintain equipment are in place Requalification Review and approve re-qualification of equipment and utilities as per Protocol and SOP Governance, Risk and Compliance Oversee compliance within strategic and operating guidelines and policies for department(s)/ function(s) Ensure recordkeeping complies with legal requirements and provide input into changes to policies in this regard Provide recommendations for development of risk-based compliance systems in order to improve overall compliance performance of the organisation and/or department/function. Background/experience Minimum of Bachelor’s Degree and 10 years’ related experience Management experience Experience in validation techniques in a Pharmaceutical Industry Specific job skills Advanced understanding of Qualification and Validation principles Knowledge of control, instrumentation, and electrical systems Understanding of pharmaceutical manufacturing and corrective action programs Pharmaceutical standards and compliance requirements Ability to interpret and implement policies, processes, and objectives Competencies Translating strategy Interpreting and internalising information Interrogating information Offering insights Managing performance Accountability & Decision Rights Develop, communicate, manage, and implement corporate and divisional strategic plans and budgets, policies and procedures Independent Decisions relating to: Design and implementation strategy for programmes and processes Interpretation and execution of and recommendations on policy/ procedure related modifications Short- and long-term department schedules, quality, compliance and resource allocation Operational objectives and work plans, and delegation of assignments Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos. LI-YM1
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