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Senior Quality Specialist

Date: Aug 14, 2019

Location: Baldoyle, IE, D13

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

We would like to invite applications for the role of Senior Quality Specialist at our site in Baldoyle. The position incumbent is expected to adhere to all cGMP compliance and regulatory mandates and quality requirements, and comply with all SOPs and internal Tosara policies and procedures in the performance of job duties. The Senior QA Specialist applies skills and knowledge to recognize and resolve issues that impact efficiency, throughput, quality, and/or the fulfilment of the assigned performance targets. The Senior QA Specialist is responsible for the safe, compliant, and efficient execution of job duties in a team environment. This position reports to the Qualified Person.

Job Description

Detailed Responsibilities:

• Perform assigned task in accordance with procedural requirements and scheduled timelines.  Notify supervisor and other impacted stakeholders if procedural requirements or timelines are not being met.
• Understand cGMPs and procedural requirements for your area of responsibility and be a resource to operators and other personnel to ensure compliance to these requirements.    
• Assess and understand events that may not be in accordance with procedures or cGMPs.
• Make decisions consistent with job responsibilities, regulations and procedures and policies.  Provide appropriate comments to cGMPs documents, when needed.  Provide timely feedback and details to supervision and other impacted personnel.
• Perform routine review of documentation generated by personnel such as BMRs, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development products for accuracy, completeness, and compliance to GMP and procedural requirements.
• Author documents that ensure cGMP compliance, such as Standard Operating Procedures, investigations, reports and forms.
• Develop and maintain metrics for trends and key performance indicators.
• Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences.
• Draft, review, and approve qualification documentation for production equipment.
• Draft, review and approve cleaning validation protocols and reports.
• Draft, review and approve Product Quality Reviews.
• Draft, review, and approve SOPs, Site Master Files, forms, and other documentation, as required.  Track and publish review schedules.  Follow-up with authors, reviewers and approvers to assure review schedules are met.
• Initiate, facilitate, monitor, trend Change Control, Complaints, Deviations, CAPAs and other Quality System documents as required.
• Support and adhere to established processes and productivity targets.
• Observe established escalation process for issues impacting established production-related SLAs (Service Level Agreements) and/or fulfilment of production goals.
• Provide status updates on own activities and productivity challenges according to defined procedures.
• Seek process innovation and continuous process improvement.
• Complete and conform to all training requirements for job role, including company-required and job role-specific training. 
• Carry out and assist in the on-going training of new and existing personnel, as appropriate.
• Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
• Consistently live and display our Shingo behaviours, even when it might be unpopular or personally inconvenient to do so. Sets a personal example that reinforces Tosara’s culture, reputation and standards.
• May participate in department initiatives and projects.
• Other responsibilities, as assigned

Education

• Bachelor’s Degree required. Chemistry or Life Science degree preferred. Some exceptions made for those candidates demonstrating equivalent knowledge and having pharmaceutical experience.

Experience & skills

• Prior pharmaceutical quality assurance experience.
• Knowledge of cGMP requirements and practices preferred.
• Strong analytical skills and knowledge of quality systems.
• Demonstrated written and verbal communication skills.

Knowledge:
• Computer literate; proficiency in using LIMS systems and Microsoft Office suite

Function
Quality
Sub Function
Manufacturing Quality Assurance
Reports To
In process of validation
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.