QC Associate - Microbiologist

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.

- Manages the micro activities on-site

- External micro activities

- Water Systems qualifications and Cleanroom qualifications activities (incl risk assessments, OQ, PQ)

- Works together with internal stakeholders, Utilities, Quality Assurance (QA), Quality Control (QC), Warehouse and Production (leads investigations, preventive actions, corrective actions, action plans and change controls)

- Responsible for authoring, review of micro documentation across site (procedures, specifications, protocols, annual quality reports (trending), risk assessments and quality agreements).

- Co-ordinates sampling of EM, water sampling on site

- Quality internal and external audits. FDA, HPRA, Corporate and Customer audit

- Training new and existing employees

- Liaises with the contract laboratory to ensure analysis, result release and investigations are on track and to manage any issues that arise.

- Prepares protocols for method transfers/validation, provide guidance for execution and approval of reports

- Review external analysis CoA including any OOS

- Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry, Biochemistry or Health Sciences field

- Typically requires 3-5 years of relevant experience in a pharmaceutical QC laboratory environment (mandatory)

- Hands-on experience in Analytical Chemistry and QC procedures (mandatory)

- Training and experience of GMP and ICH guidelines standards (mandatory)

- Knowledge on HPLC and GC, and familiarity with Empower Software (desirable)

- Strong understanding and knowledge of GMP practices, analytical theory and techniques

- Fluency in English is a requirement

- Computer literate with good working knowledge of the MS Office package

- Good documentation skills and attention to detail

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.

Notice to Agencies and Search Firms Representatives
Hovione does not accept unsolicited résumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral. Thank you for your understanding.