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 Process Facilitator in Philadelphia, PA, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK
The PET Process Facilitator is a leader for the Process Operation (i.e. Formulation / Packaging). In this capacity the Process Facilitator manages the Operation to produce high quality product in accordance with the PET operating strategy. As a responsible leader for the operation (potentially with other Process Facilitators), this must be done while maintaining effective employee relations and compliance to SHE, cGMP, AstraZeneca standards, other regulatory, and SOX requirements.
Responsibilities:
- Provides direction to PET personnel in the efficient use of equipment and materials to produce quality products in accordance with the PET plan.
- Responsible for all PET activity to include coordination of support staff, scheduling and improvement.
- Promotes the use of safe work practices during all aspects of production and ensures all external and AstraZeneca SHE standards are met on a daily basis.
- Accountable for training PET personnel on equipment, processes and standard operating procedures.
- Ensures that cGMPs are used and followed during production of products so that all FDA and international regulations are met.
- Promotes a positive work environment by effectively administering AstraZeneca Human Resource policies and procedures including Performance Management and by communicating information to employees and responding to their concerns.
- Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
- Generates reports for deviations, assists in the investigations, and recommends / implements solutions to resolve deviations. Approves deviation investigations as appropriate.
- Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
- Collaborates with CI Engineers, PET Engineers and Maintenance Facilitators to optimize process performance.
- Participates in the design, selection, installation and qualification of new equipment, facilities and processes.
- Reviews, approves and implements change control as appropriate.
- Provides career development for direct reports.
- Works collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors.
- Acts as backup to PET Lead when designated.
- Ability to work any shift and collaborate with other Process Facilitators across shifts.
Qualifications:
Education:
- Bachelor of Science in Engineering, Pharmacy, related Science or business
Required:
- Minimum of five (5 )years’ experience in a GMP or regulated product environment
- Minimum of one (1) year previous supervisory experience
- Knowledge of FDA cGMP’s
- Strong communication and leadership skills
- Strong troubleshooting and problem solving skills
Preferred:
- Experience working in a Lean Manufacturing environment
- Ability to direct and participate in cross-functional teams
- Knowledge or previous experience in managing technical programs/projects
- Training or experience in formulation, filling, packaging, validation, technology transfer, change control
- Project management skills
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.
Date Posted
29-Jan-2020Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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