This job is currently Archived,
Posted on : 04 June 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- Provides to the site and network, expertise in Quality Systems and/or Operational Quality, including the following i.e. Deviation/NOE/LIR coaching; GCM coaching; environment monitoring programs; sterile assurance; customer compliant investigations; etc.
- Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
- Coordinates the work of others within the team and in the site
- Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality
- Leads project teams.
- Coaches and guides colleagues within the site and also in the network.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes
- Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
- Makes decisions within guidelines and policies which impact Product Quality, Projects and Quality Systems.
- Liaises with Corporate Quality to ensure alignment on actions related to Quality Systems and/or Operational Quality at the site.
- Coordination and/or participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
- Ensure supply of high quality product through implementation and oversight of the Quality Management System for the site.
- Works with other sites to aid them and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
- Champions Permanent Inspection Readiness (PIR) and Quality and Compliance Excellence (QCE) programs.
- Ensure the highest Quality, Compliance and Safety standards.
- The Principal Quality Specialist will participate and comply with the MM
- Quality Management System (QMS) requirements, including ownership.
- Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools within the IPT
- The Principal Quality Specialist will have proven capability in development of Quality Systems across cross functional teams to deliver process improvement.
- Model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.
- At least 5 years experience in the Pharmaceutical industry or a similar operating environment which includes a minimum of 2 years experience in a Quality function.
- Experience as QMS Sub System Owner as required for the Principal Quality Specialist role
- SME in at least 4 QMSs as required for the Principal Quality Specialist role
- Degree (in Science).
- Green belt or suitable alternative.
- Demonstrated change management skills (CEM) with continuous improvement.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc).
- Quality Assurance SME knowledge from both operational and educational experience, is required
- Demonstrated expertise in Quality Management Systems.
- Demonstrated use of Leadership Behaviours
- Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
- Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance.
- Demonstrated ability to co-ordinate the work of others, as well as leading project teams.
- Demonstrated ability to drive the completion of tasks.
- Proven track record of providing independent Quality expertise to the site.
- Demonstrated delivery of SME knowledge above site.
- Demonstrated successes in a team environment, such as project teams, Six Sigma team, Tier 4s etc.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
- Proven decision making capability with full accountability and responsibility.
- Demonstrated coaching skills
- Demonstrated ability to clarify, communicate and solve complex problems.
- Our employees are the key to our company s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Travel: Yes, 5 % of the Time
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