Manager, Validation - Mount Vernon, IN | Biospace
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Manager, Validation

AstraZeneca Pharmaceuticals LP

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Location:
Mount Vernon, IN
Posted Date:
6/22/2017
Position Type:
Full time
Job Code:
R-003070
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location:Mount Vernon, Indiana, United States
Job reference: R-003070

Posted date: Jan. 20, 2017



At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Validation Manager at the Mount Vernon, IN site, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

As the Validation Manager
you are responsible for the site Master Validation Plan and ensure that qualification and validation systems are in compliance with regulatory guidelines and standards.

Responsibilities include:

Operations

  • 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.
  • Develops, implements, integrates, and sustains validation systems to enhance compliance in accordance with ICH guidelines Q8, Q9, and Q10.
  • Creates and implements changes in the Qualification programs to enhance compliance, reduce costs, improve customer service, and strengthen technical base.
  • 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.
  • Serves as a subject matter expert for process, packaging, and cleaning qualification and validation systems for site regulatory inspections.
  • Collaborates with R&D during technical transfers to integrate process analytical technology (PAT) and system controls within the Quality by Design framework.
  • Develops and maintains effective relationships with internal and external customers, regulators, and other stakeholders.
  • Updates, reviews, and approves area procedures to ensure compliance with Good Manufacturing Practices.
  • Solves qualification issues using critical analyses skills; develops sound, reasoned solutions and recommendations.
  • Evaluates new projects or existing equipment modifications, in terms of qualification and calibration needs, regarding the quality impact.
  • Manages the qualification activities associated with all Quality Investigations.

Quality

  • Participates as a member of the site Quality Council.
  • Coordinates and participates in the investigation and resolution of product quality problems.
  • Leads and participates in organizational teams to promote continuous quality improvement.

Financial

  • Makes effective financial and operational decisions to positively impact both short and long-term objectives.
  • Ensures that cost improvement projects are completed to meet the preset goal.

Organizational

  • Develops and maintains an effective organization through effective selection, training and development, and performance management.
  • Prepares annual reviews and discusses job performance with area staff. Reviews and approves transfers, promotions, merit increases, and disciplinary actions.

Safety

  • Works in partnership with site SHE to ensure validation systems comply with environmental and safety regulatory standards.
  • Maintains a safe work environment by ensuring that Department personnel follow site SHE policies and procedures.

WORK ENVIRONMENT and CONDITIONS:

  • 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.
  • This position works in MTV pharmaceutical production areas that require appropriate uniform, gowning, and PPE.
  • Minimal travel required.

TYPICAL ACCOUNTABILITIES:

  • 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.
  • 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.
  • 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.
  • 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.

Requirements

Essential Requirements:

  • Bachelor's degree required, preferably in Chemistry or Industrial Pharmacy.
  • Strong understanding of cGMPs, demonstrated leadership, management, and technical capabilities.
  • Demonstrated applied knowledge of ICH guidelines Q8, Q9, and Q10, statistical process control, and PAT.
  • Excellent verbal, written, and interpersonal communication skills are essential. Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and operations staff.
  • Must have demonstrated ability to plan, implement, and achieve significant, complex goals and objectives.
  • Experience in conceptual development, project management (planning and scheduling projects), design, and implementation of major capital projects.
  • Strong understanding of cGMPs, demonstrated leadership, management, and technical capabilities.
  • Knowledge and understanding of validation and qualification principles, project management, and change control principles.
  • Ability to understand and utilize financial analyses to make good decisions in a manufacturing environment.
  • Demonstrated ability to manage a multi-disciplined technical staff.

Desirable Requirements:

  • Master's degree is highly desirable.
  • Six Sigma green belt or equivalent experience is preferred.
  • Experience with IQ/OQ/PQ and Lean Manufacturing is highly desirable.
  • Experience in the pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.
Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

~bsp