Qualified Person (QP)

PharOS Ltd in Malta is currently seeking to recruit a Qualified Person (QP) to join their team on a full/part-time basis.

Key Responsibilities:

• Act as one of the nominated Qualified Persons on the Company’s licence for the release of pharmaceutical products to market or to study sponsor in the case of IMP’s
• Provide QP GMP declarations including on site audits if required
• Review study and lot specific documentation necessary to facilitate QP Release. Use technical knowledge to assess the criticality of any issues
• Liaising with the Regulatory Authorities
• Provide support for resolution of technical problems involving existing global supply products
• Actively encourage input/development of QMS, Site Quality/EHS Councils and Continuous process improvement
• Manage the batch disposition process to ensure timely release of product
• Experience in auditing suppliers, consultants, API facilities, and drug product manufacturing or testing sites
• Ensure the batch disposition process maintains compliance with site practices & regulatory requirements
• Support major investigations, ensuring all product deviations are closed prior to batch release
• Provide advice and direction to other departments on quality issues
• Ensure independence of the QP on decisions on quality related matters
• Build partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.

Requirements:

• Bachelor’s Degree in Chemistry, Pharmaceutical Science or related field from an accredited college or university
• Registered as a Qualified Person with the Pharmacy Council
• Excellent English oral communication and writing skills
• Excellent organizational and communicational skills
• Team working spirit
• Ability to deliver under specific and demanding deadlines.

PharOS Ltd Offers

• Competitive remuneration package (including bonus based on performance)
• Private medical scheme
• Continuous training
• Friendly and challenging working environment
• Relocation package.

PharOS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, gender expression, national origin, or any other basis protected by applicable law, and will not be discriminated against on the basis of disability.