Quality Assurance Documentation Associate

Join a Market Leader

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

 

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

 

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

You will be responsible to:

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of product documentation and operations throughout the products lifecycle. Provides GMP documentation services in support of new product introduction and existing products. Collaborates with site QA and other stakeholders to assure the quality documentation of their products, materials, components and/or operations.

• Rigorously, accurately, efficiently and professionally manage all quality documentation activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready”
• Promote the importance of high-quality levels and the importance of a continuous improvement culture in support of GMP documentation activities
• Act as a catalyst for change and improvement in performance/quality
• Assigned projects may relate to any of the following (non-exhaustive) areas:
  • Responsible for the administration of Documentation Systems, maintaining the compliance of documentation control
  • Ensure accuracy, completeness, and conformity of all prepared documents per the Quality Systems
  • Manage electronic controlled document directory structure and maintain accurate indices of contents
  • Responsible for issuance, distribution and update of controlled documentation in the documentation management system and, for the controlled hard copies as applicable
  • Oversee the verification and reconciliation process for controlled documentation populated with GMP data and, manages access requests
  • Liaise with Corporate IT to manage the distribution groups in Documentation System as applicable
  • Propose and/or assist in the review and revision of procedures (COP, SOP, IOP), reports, specifications and/or record forms; supports preparing or authors associated training materials
  • Oversee the generation, distribution and tracking of site-wide equipment logbooks, analyst notebooks, project notebooks, etc.
  • Execute all aspects of ValDoc systems to ensure availability and organization of GMP documentation
  • Generate correspondence and facilitate the transference of regulatory documents to external stakeholders and maintain files to support all documentation systems
  • Supervise timely preparation and delivery of electronic copies to clients: executed batch records, stability data, reference standard qualifications, method validation packages, etc.
  • Prepare welcome packets and assembles pre-requested audit documentation in advance of client audits
  • Work closely with the Audit Manager during client audits and regulatory inspections, facilitating the prompt location and delivery of requested documents to the audit room, and ensure that all original documentation is returned to the archive accordingly
  • Serve as Administrator and Key User of electronic document management, archive management and training management systems, providing ongoing training and support to users
  • Provide support on the validation/requalification execution activities of the systems under department ownership. These activities include supporting the development of validation/qualification protocols, executing the protocols, and generate the reports
  • Execute archival of GMP documents (on-site and of-site documentation storage)
  • Upon management discretion, acquire necessary data and prepare routine reports:
    • Annual water, microbiological monitoring (at rest and in operation) and pest control reports
    • Prepare annual plans (and related reports) for Quality Assurance: periodic revision of procedures, GMP training, internal audits