Supplier Quality Specialist

at  McKesson

EDUCATION/TRAINING:

Educated to degree level, minimum B.Sc. (Biological or chemical sciences) or B.Eng, (process and Chemical)

EXPERIENCE:

2+ years pharmaceutical manufacturing experience in a regulated facility
Broad knowledge of at least one manufacturing dosage form
Experience of laboratory, with considerable expertise in at least one dosage form

KNOWLEDGE AND SKILLS:

• Pharmaceutical quality assurance experience preferred
• An understanding and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment
• An understanding of basic pharmaceutical processes such as a solid dose manufacturing process, aseptic manufacturing processes, packaging process, etc.
• Experience in risk management tools and techniques
• Ability to communicate with suppliers to improve performance; including the ability to influence through effective communication and diplomacy
• Ability to work independently and make decisions based on judgement and integrity
• Proven analytical skills and ability to transfer findings into well written report formats
• Ability to work effectively with others to accomplish goals
• Demonstrates and understands customs and beliefs of various groups or cultures
• Experienced in operating under a Quality Management System
• Strong communication and interpersonal skills
• Effective team building ability
• A continuous improvement mindset

PURPOSE OF JOB

The post holder will provide experience and technical support in overseeing contract manufacturing organisations and service providers to ensure McKesson private label products are manufactured and distributed in compliance with internal procedures, FDA and Health Canada regulations. The post holder will participate as a team member managing data which facilitates monitoring supplier activity to ensure compliance, manage risk and minimise supply interruptions across McKesson private labels including Strategic Sourcing Services LLC (SSSL); Northstar Rxllc and McKesson Corporation dba SKY Packaging

KEY RESPONSIBILITIES

• Execution of Quality Management System activities as it applies to Supplier Quality functions
• Generation of departmental metrics and KPIs
• Surveillance of regulatory authority actions impacting business operation
• Generation and distribution of supplier scorecards
• Tracking and maintenance of quality agreements
• Provision of GMP documentation in adherence to quality agreements
• Documentation control arising from Quality Systems action items
• Preparation of annual site risk assessments
• Support the preparation and periodic review of Supplier Quality SOPs.
• Partner with Supplier Quality Auditors to enhance departmental audit processes.
• Support McKesson Enterprise Quality initiatives
• Work in accordance with I2CARE and ILEAD principles
• Foster a culture of learning and engagement, empowering technical judgement and decision making
  (The above statements describe the general nature and level of work being performed in this job. They
  are not intended to be an exhaustive list of all duties)