|Date Posted||May 14, 2021|
|Address||645 Science Drive|
Your role: The Quality Assurance (QA) Compliance representative is a highly dynamic position providing compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel.
A QA Compliance representative provides broad compliance support to cross-functional teams in support of the following quality management systems or processes such as deviation management, CAPA management, change control, risk management, data integrity, quality management and annual product reviews, supplier quality management, quality agreements, training, field corrective actions, coordination of and participation in regulatory and customer audits, complaint management and divisional policy implementation and compliance. Responsible in collaboration with the site personnel for ensuring that the site is in a state of continuous inspection readiness.
Roles and responsibility: QA Compliance reps possess detailed knowledge of cGMP and site quality systems with strong evidence of collaborating in a matrix environment. Highly developed interpersonal, written and verbal skills, including the ability to communicate with internal and external customers and represent the Madison/Verona quality management system. The QA Compliance representative establishes strong collaborative relationships with all departments within the organization to deliver on timely quality performance metrics within the QMS.
The responsibilities of the role include:
- Develops and implements programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement. Implements policies, procedures and methods to check product, material, components and/or operational quality and improve same.
- Ensures quality of products, services and suppliers in compliance with product claims, external regulations and customer quality requirements.
- Maintains and communicates a clear quality vision for the safe, efficient and compliant production of APIs and other GMP compounds.
- Ensures the organization has an ‘Inspection Ready’ program with personnel preparation for hosting inspections and inspection follow up.
- Maintains Site’s Quality and Regulatory Heat Map with responsibility for risk reduction programs and support the initiation and review of quality improvement plans.
- Provides GMP training and governance to the site and responsible for site training program (Learning management system (LMS).
- Ensures that Deviations and CAPAs are compliant to GMP and managed to completeness in a timely manner within TrackWise.
- Ensures that the Change control programs follow adherence to GMP and closure times and the management of TrackWise.
- Approves changes that potentially affect intermediate or API quality.
- Participates in the site’s Data Integrity plan and execution as per project plan.
- Manages customer complaints and associated reports making sure that quality-related complaints are investigated and resolved.
- Responsible for the implementation of policies, procedures and methods to check product, material, components and/or operational quality and ensures implementation of corporate policy and procedures.
- Approves or reviews all procedures affecting the quality of intermediates or APIs.
- Facilitates and supports customer and regulatory audit program.
- Ensures that internal audits (self-inspections) are performed.
- Reviews and approves method validation protocols/reports and equipment qualification protocols/reports as assigned.
- Prepares and performs QMR and APR appropriate to the GMP and products.
- Ensures cleaning strategy and acceptance criteria of the Site meet the required standards.
- Frequently interacts with internal teams to support product license and regulatory submissions with the regulatory affairs group.
- Maintains the Approved Supplier List (ASL) including updating and reviewing performance of vendors and ensuring Quality Agreement with vendors are established and maintained.
- Approves intermediate and API contract manufacturers and testing facilities.
- Provides compliance review for documentation including change controls, deviations, validation documentation, SOPs and specifications.
- Manages Customer Quality Agreements.
- Providse Quality Compliance support to new product introduction (NPI) activities.
- Reviews requests for major changes and PDP/TDP gate reviews and makes recommendations.
- Manages critical quality incidents and Field Corrective Actions (FCA) and product returns as necessary, interact with authorities with the support of the regulatory team.
- Supports the initiation and review quality improvement plans.
- Collates and deliver weekly and Monthly KPIs to Management, as requested.
Who you are:
- Bachelor’s degree in Chemistry, Chemistry Engineering, Pharmacy, Biochemistry, Biology or a related science.
- 5+ years of applicable experience (cGMP pharmaceutical quality assurance experience is preferred)
- Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210, 211 and 820) and ICHQ7 Good Manufacturing Practice Guidance for APIs.
- Knowledge in 21 CFR Part 11 and Data Integrity Guidelines for pharmaceutical manufacturing
- Competent knowledge of and ability to use Microsoft Word, Excel and Access.
- Excellent organizational, written and verbal communication and interpersonal skills
- Results driven, team player, able to deal with multiple projects/tasks