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Quality Assurance Quality Steward, Pre-Commercial

Expired Job

Mayne Pharma Group Limited Greenville , NC 27833

Posted 3 months ago

Position Overview

This position will provide quality oversight and a single, consistent quality approach for the pharmaceutical development/CTM manufacturing and Metrics Contract Services analytical teams. This role requires the ability to lead and train Quality Assurance professionals in day-to-day activities, supporting the review and release of development/CTM drug products manufactured, packaged and/or analyzed at the Greenville, NC, site.

Key Responsibility Areas

  • Project Coordination: Lead the scheduling and planning of work in assigned areas to assure the highest levels of efficiency and quality are met; represent the Quality Assurance department on pharmaceutical development project teams

  • People Development: Assist with the career growth development of assigned team members by providing on-the-job training, mentoring and guidance

  • People Leadership: Lead in the development of a culture, and supporting systems, to drive open communication, participation and intra/inter-departmental idea-sharing to build an engaged team; advance and model Mayne Pharma values and leadership commitments; ensure the highest levels of quality, compliance and integrity are adhered to in all interactions

  • Process Improvement: Monitor manufacturing process and testing data outputs for opportunities to make product processes and testing more robust; identify and recommend opportunities for improved efficiencies, client service and teamwork within the manufacturing support and analytical review functions

  • Special Project Leadership: As assigned, lead various projects requiring inter-departmental inputs and coordination aimed at improving efficiencies, quality and service across the organization

Specific Responsibilities

Responsibilities include, but are not limited to:

  • Acquire product-quality knowledge and act as the quality expert for the product-quality history throughout the product life cycle.

  • Mentor and guide a team of QA staff members at various levels supporting the product development and contract services; ensure that all quality data is recorded and reported to support contracted activities

  • Lead in the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards

  • Evaluation of batches for release/rejection

  • Review and approve pre-execution batch records and completed batch records

  • Review and approve change management activities

  • Review and approve deviation and laboratory investigations in the site eQMS

  • Review and update SOPs for GMP compliance

  • Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function

  • Participates in CMO/CPO audits

  • Assist with compliant investigations for development and CTM products

  • Act as QA representative on project teams

  • Ensures compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable).

  • Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules

Key Competencies/Requirements

  • Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others

  • Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems

  • Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services

  • Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates

  • Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas

  • Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people

  • Communication: Deliver clear, effective communication and take responsibility for understanding others

  • Quality: Support Quality and Data Integrity principles in every action and activity, visibly prioritizing quality and helping to transfer and reinforce quality in our environment

Qualifications

  • Master's degree in chemistry or related field with ten years of professional experience in the pharmaceutical industry, preferably with five years in a QA role

  • Bachelor's degree in chemistry or related field with ten years of professional experience in the pharmaceutical industry, preferably with five years in a QA role

General Statement

Mayne Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.


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Quality Assurance Quality Steward, Pre-Commercial

Expired Job

Mayne Pharma Group Limited