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Manager, Validation

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POST DATE 8/24/2016
END DATE 10/29/2016

AstraZeneca Pharmaceuticals LP Mount Vernon, IN

Mount Vernon, IN
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


Do you have a desire to join a team that is improving and enriching the lives of others? Do you have a vision to be part of a world-class manufacturer of innovative medicines for patients, and a manufacturer that is admired for its performance, its people, and its partnerships? Through your contributions you will be helping support the manufacturing of products using current Good Manufacturing Practices. You will become part of a rapidly growing team that is recognized and rewarded for their commitment. You will be working in an environment that is dynamic, entrepreneurial and fosters collaboration and innovation - and where you will make a real impact. So, be part of the team which makes us an innovation-driven, science-led company, standing firmly among the world's leaders in biopharmaceuticals. The Validation Manager is responsible for the site Master Validation Plan and ensures that qualification and validation systems are in compliance with regulatory guidelines and standards. br br br JOB RESPONSIBILITIES: br Operations br br * Responsible for site Qualification and Validation Plans that include process validation, packaging validation, cleaning validation, equipment qualification, utilities and facilities qualification, and computer system validation. br * Develops, implements, integrates, and sustains validation systems to enhance compliance in accordance with ICH guidelines Q8, Q9, and Q10. br * Creates and implements changes in the Qualification programs to enhance compliance, reduce costs, improve customer service, and strengthen technical base. br * Collaborates with various engineering system owners such as process, packaging, and automation to reduce product cost and increase productivity while sustaining or improving the validated systems. Manages and controls validation documents for the Technical Services Department. br * Serves as a subject matter expert for process, packaging, and cleaning qualification and validation systems for site regulatory inspections. br * Collaborates with R&D during technical transfers to integrate process analytical technology (PAT) and system controls within the Quality by Design framework. br * Develops and maintains effective relationships with internal and external customers, regulators, and other stakeholders. br * Updates, reviews, and approves area procedures to ensure compliance with Good Manufacturing Practices. br * Solves qualification issues using critical analyses skills; develops sound, reasoned solutions and recommendations. br * Evaluates new projects or existing equipment modifications, in terms of qualification and calibration needs, regarding the quality impact. br * Manages the qualification activities associated with all Quality Investigations. br br Quality br br * Participates as a member of the site Quality Council. br * Coordinates and participates in the investigation and resolution of product quality problems. br * Leads and participates in organizational teams to promote continuous quality improvement. br br Financial br br * Makes effective financial and operational decisions to positively impact both short and long-term objectives. br * Ensures that cost improvement projects are completed to meet the preset goal. br br Organizational br br * Develops and maintains an effective organization through effective selection, training and development, and performance management. br * Prepares annual reviews and discusses job performance with area staff. Reviews and approves transfers, promotions, merit increases, and disciplinary actions. br br Safety br br * Works in partnership with site SHE to ensure validation systems comply with environmental and safety regulatory standards. br * Maintains a safe work environment by ensuring that Department personnel follow site SHE policies and procedures. br br WORK ENVIRONMENT and CONDITIONS: br br * This is a day shift position. Off-shift and weekend support is required as needed to ensure production, projects, and site goals and objectives are met. br * This position works in MTV pharmaceutical production areas that require appropriate uniform, gowning, and PPE. br * Minimal travel required. br br TYPICAL ACCOUNTABILITIES: br br * Conducts activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to this role. Completes all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Reports potential issues of non-compliance. br * Ensures and monitors compliance by team members and third parties by a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, b) ensuring completion of all required training, c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and d) immediately addressing and reporting, as appropriate, instances of non-compliance. br * Manager accountabilities at Astra Zeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness. br * Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality System and continually improve its effectiveness.