QP / Qualified Person - Vaccines
A large biotechnology company are seeking a Qualified Person to join their Quality Assurance Operations team in Prague, with a specific interest in Vaccines. The talented individual will be responsible for the oversight and global realse of commericial and clinical products. You will develop strong relations with QA Operations, compliance and directives.
- Assists in defining, implementing and executing a global strategy with multiple US and ex-US CDMO partners and company sites to ensure product is consistently developed, manufactured, tested, labeled, released, and shipped to in compliance with international regulations including EU, MHRA and ROW GxP requirements.
- Responsible for ex-US global QP product releases
- Works with other QA Operations Leads to coordinate and provide oversight of lot release for bulk drug, drug product and packaged product for clinical and commercial use in the EU/UK/ROW.
- Works closely with QA Operations Lead, QA Compliance Lead and QA Clinical Leads in supporting EU/UK/ROW related activities as needed including but not limited to auditing, oversight of contractors, training on EU/UK Regulations and Directives
- Serves as a EU/UK/ROW technical resource or subject matter expert on manufacturing and techniques within Quality Assurance
- Review and approval of manufacturing technology transfer, qualification and validation documents internally and oversight activities to CDMOs as needed
- Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Quality System activities.
- Effectively cooperates with departments across the company and partner sites to analyze and resolve technical issues in accordance appropriate quality standards.
Skills and Requirements:
- BSc in Biology or Chemistry; MSc preferred
- 10-15 Years industrial experience in Pharmaceutical Industry with focus on biologics products
- Eligible Qualified Person under the provisions of Directives 2001/83/EC and 2001/82/EC
- Thorough knowledge of ICH E6 (R2) and Directive 2001/20/EC
- Experience in providing QP Certifications for relevant filings in EU/UK/ROW
- Previous experience auditing of contract manufacturers and testing labs and suppliers
- Experience in aseptic processing preferred
- Thorough knowledge of implementing Risk Based approach to Quality Systems and the associated risk assessment tools as per ICH Q9
- Demonstrated verbal and written skills in communicating regulatory and technical information
- Strong command of the English language and demonstrated editing skills
- Flexible and adaptable to changing priorities. Ability to work under pressure within tight time frames
- Strong communication and organizational skills
In addition to a base salary, this organisation also offers an annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.