Hovione Hiring for Quality Assurance Administrator Job at Cork , Ireland Full Time

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::

• Responsible for the administration of QA Documentation Systems, maintaining the compliance of documentation control for the Hovione-HE group.
• Carries out responsibilities in accordance with Hovione policies and procedures, and as per cGMP Guidelines and other regulatory standards, triggering actions if necessary.
• Ensures accuracy, completeness, and conformity of the QA document system.
• Manages electronic controlled document directory structure and maintains accurate indices of contents.
• Issues, distributes and updates controlled documentation.
• Prepares month-end Compliance KPI reports and distributes information to General Manager, Corporate Compliance, etc.
• Processes, issues and tracks batch record and other manufacturing documentation.
• Propose and/or assist in the review and revision of procedures (e.g., COP, SOP, IOP), reports, specifications and forms.
• Prepares, distributes and monitors usage of equipment logbooks, analyst notebooks, etc.
• Coordinates correspondence and transference of regulatory documents to FDA, IMB and other regulatory bodies and maintains files to support all documentation systems.
• Organizes completed batch production records, prepares and distributes electronic copies to clients.
• Provides support to the QA team in preparing for, and during, audits to the HE facility.
• Key user of electronic document management system and provides training and support to users.
• Reviews, compiles and prepares records for annual performance reviews.
• Maintains QA employee training records, summarizes forecasted training requirements and provides quarterly this information to the department heads.
• Maintains all Quality System files and archives.
• Performs duties in a timely manner and complies with all Company policies and procedures including safety rules and regulations.
• Any other tasks which may reasonably be required in accordance with the business needs and keeping with the nature of the role.

We are looking to recruit a Candidate::

• Education to degree level or equivalent in Quality Assurance or other science discipline
• Working knowledge of Quality Assurance systems and GMP
• Two years of experience withinindustry quality control and/or quality assurance practices and systems
• Have excellent attention to detail and process-oriented
• Experience creating procedure documents
• Proficient with MS Office Suite; experience creating spreadsheets
• Very organized with the ability to take charge of and complete projects
• Able to work independently and in a team environment
• Able to prioritise responsibilities and adhere to deadlines

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.