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West Pharma Quality Systems Specialist United States, Pennsylvania, West Whiteland Township 837785938
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Essential Duties and Responsibilities
- Perform activities for creation, issuance and review of customer notifications relating to West change controls.
- Coordinate customer notification process across cross functional teams, which includes direct communication with change owners to define appropriate change notification information, impacted customers and customer approval process, if needed.
- Assist in activities of Change Control Review Board(s)(CCRB) and Medical Device Change Control Review Board (MDCCRB). This includes facilitating cross functional team discussions and documentation of meeting details and outcome.
- Engage with cross functional teams during change initiation to ensure information relating to customer notification/engagement is evaluated during change execution.
- Support West customer facing teams to provide support on Customer Notifications/ communication of change.
- Hold monthly change meetings with customers, as applicable, to communication information on upcoming changes. Provide feedback to change owners and update customer notifications, as needed.
- Maintain CCRB and MDCCRB metrics and customer notification metrics for trending, analysis, and reporting.
- Maintain the change control customer notification history, records and documentation to demonstrate compliance to regulations and company policies, procedures and requirements.
- Assist areas for training on change control and customer notification procedures and key compliance requirements as applied to West products and processes.
- Support initiatives for the development of digital strategies to enhance change control and customer notification processes.
- Support corporate harmonization initiatives as they pertain to the quality management system.
- As appropriate, use knowledge and experience to identify initiatives to improve the effectiveness and/or efficiency of systems.
- Work independently with supervision.
- Other duties as assigned.
Education
- Bachelor's or Masters Degree in science preferred or equivalent experience in related discipline required
Work Experience
- Minimum 3 years Quality related experience required
Preferred Knowledge, Skills and Abilities
- Experience in regulated industry such as pharmaceutical or medical device.
- In depth knowledge of cGMP, cGDP, relevant ISO standards
- Experience with SAP systems
- Familiarity with document management databases, particularly MasterControl.
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
- Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making
- Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of customer visits and business development related activities
- Work in an office environment. At times must sit for extended periods of time.
- Observe and interpret situations, analyze and solve problems
- Must maintain the ability to work well with others in a variety of situations
- Must be able to multi-task and work under time constraints
- Ability to make independent and sound judgments
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