Senior QA Compliance Specialist - (Mount Vernon, IN) AstraZenecaLocation: Mount Vernon, Indiana, United States
Job reference: R-016230
Posted date: Oct. 25, 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 Senior QA Compliance Specialist in Mt, Vernon, IN, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
The Senior QA Compliance Specialist provides routine site support for Quality Compliance; provides leadership and coaching to the site for the development and execution of GMP Quality Systems.
- You will ensure appropriate GMP Quality Systems are in place through review and approval of documentation and shop floor presence. You will interface with site departments to ensure systems, processes, facilities, utilities, equipment, and instruments are in accordance with current Good Manufacturing Practices.
- You will lead and support site regulatory inspections; interface with Regulatory Agencies during inspections. You will participate in the preparation of document packages and responses to regulatory agencies.
- You will review and approve site GMP required procedures and ensures alignment and compliance with AZ Corporate Compliance, Global site reviews, and WWQ&C Policies and Directives.
- You will be responsible for the site internal audit program and for conducting internal audits of site GMP systems and processes.
- You will conduct compliance audits for external vendors and service suppliers at frequency assigned by AZ Worldwide Quality. Approve Qualification reports for new raw materials/vendors.
- You will coordinate site activities for Field Alerts, Fact Finding activities, product recalls, market withdrawals, and other regulatory actions when authorized by Worldwide Quality & Compliance or as required by local regulatory agencies.
- You will author, review, and approve documents including standard operating procedures (SOPs), protocols, deviations, CAPAs, reports, and other GMP documents as required.
- You will perform document review and approval of engineering and/or validation processes to ensure compliance, effectiveness, and continuous improvement.
- You will review and approve all change controls. You will review and approve qualification reports related to equipment, utilities, and facilities qualification.
- You will work with site and corporate Information Technology (IT) group to ensure validation of GXP computerized. This includes the implementation of GMP quality systems as well as GXP systems that may require validation.
- You will provide Quality support and technical expertise to cross-functional groups and personnel on projects, as appropriate.
- You will develop and present (as needed) Quality Council slides according to the site schedule.
- You will track and report key quality metrics for the site.
- You will provide routine QA presence in the production environment to increase GMP intuition.
- You will prepare the site Annual Product Quality Review (APQR) reports in alignment with the Regulatory Annual Report schedule, WWQ&C Policies and Directives and site SOPs.
- You will coordinate, develop, and maintain site-related, raw material, and packaging component supplier’s Quality Agreements in compliance with WWQ&C Policies and Directives and site SOPs.
- You will perform/document customer complaint investigations; conducts trend analyses for site drug product customer complaints in compliance with WWQ&C Policies and Directives and site SOPs.
- You will be the System Administrator for the site TrackWise system; represents GMS in global TrackWise forums.
- You will perform GMS site Change Control Gatekeeper responsibilities to manage and support TrackWise Change Control process and activities.
- You will report emerging customer complaint trends and identifies the need for assignment of corrective action/preventive action.
- You will develop objectives and implements appropriate strategies for QA Compliance and site activities.
- You will communicate and build cooperative relationships with third-party colleagues and within AZ.
- You will conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to this role.
- You will complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. You will report potential issues of non-compliance.
- Bachelor’s degree preferred, ideally in a scientific or technical discipline. Equivalent work experience may be considered in lieu of education.
- Solid understanding and knowledge of cGMP and regulatory principles in a pharmaceutical manufacturing environment.
- Excellent interpersonal, verbal, and written communication skills with the ability to communicate across all levels of the organization.
- Proven analytical skills and ability to transfer findings into report and presentation formats.
- Ability to work in an action-oriented, fast-paced, and rapidly changing work environment.
- Ability to prioritize workload and manage multiple and varied tasks with enthusiasm.
- Experience with Microsoft Office applications including Excel, Word, and PowerPoint.
- Expertise in retrieving, assessing, and reporting analytical data and trends.
- Ability to work both independently and effectively collaborate to lead a team.
- Must have demonstrated the ability to identify GMP gaps then implement/oversee resolution of complex issues.
- Extensive experience participating in and responding to inspections by internal and external auditors.
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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.