About the role

Supervising QA associates in PCI Pharma Services ensuring compliance with regulatory standards and effective quality management. Managing external audits and collaborating with production and customer service teams.

Responsibilities

Responsible for the Supervision of the QA associates, ensuring that all site licenses are kept up to date
Hosting external client audits
Manages the KPIs and Metrics reporting to site management and Corporate
Works closely with site management, production, and customer service to ensure customer requirements and timelines are met and comply with internal operating standards and regulatory standards (cGMPs/GMPs)
Supervises the QA Associates
Provides direction on dealing with issues during production and elevates issues to Sr. Director Quality Operations and site management as required
Reviews and approves executed inspection and production related documentation
Conducts training on PCI's Quality Management Systems, processes and performs annual GMP refresher training
Initiates CAPA’s resulting from deviations, customer complaints, identified non-conformance, audits, or any other means of problem identification

QA certificate or equivalent experience
University degree / college certificate in the fields of math, science, Quality Assurance or equivalent
In-depth knowledge and experience with manufacturing and packaging processes
5 years in the pharmaceutical industry and knowledge of GMP’s
Extensive computer knowledge and adeptness with various software programs including Microsoft Word, Excel, Outlook, and Database Management
Excellent mathematical as well as written and oral communication skills

Exceptional attention to detail and accuracy in the maintenance of records and data
Excellent organizational, and time management skills to ensure deadlines are met
Effective interpersonal and teamwork skills