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Quality Assurance Specialist

2 months ago

Basildon, Essex, United Kingdom Ortolan Group Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Ortolan Group. As a Qualified Person, you will play a critical role in ensuring the highest ethical and quality standards are maintained in our pharmaceutical operations.

Key Responsibilities
  • Provide QP release activities in line with EU GMP directives and guidance for the Certification of Medicinal Products
  • Support the RP release function in line with EU GDP guidance
  • Provide GMP support and guidance for Pharmanovia and third parties employed by Pharmanovia
  • Review and approve GMP or regulatory documents as required
  • Lead Quality Investigations and root cause analysis meetings to ensure appropriate Corrective and Preventative actions have been assigned
  • Review and approve SOPs, master GMP related documentation, batch manufacturing records, validation protocols, analytical specifications, change requests, quality reviews, and planned changes in accordance with procedure
  • Review and approve Technical Agreements
  • Maintain up-to-date knowledge of regulatory requirements, including GMP/GDP, and advise colleagues, business partners, and management of implications of current and new requirements
  • Actively identify and support site continuous improvement projects
Requirements
  • Bachelor's degree in chemistry, biology, or pharmaceutical science
  • Postgraduate degree in pharmaceutical studies or equivalent is desirable
  • Eligible to be added as a QP to an MIA under the permanent provisions of Directive 2001/83/EC for Medicinal Products for Human Use
  • Registered as a member of either the Royal Pharmaceutical Society, Royal Society of Chemistry, or Royal Society of Biology
  • Experience working within a pharmaceutical company as a Qualified Person releasing Solid Dose products
  • Proven experience of hosting and supporting MHRA Regulatory Inspections
  • Experience of leading self-inspections and external audits
  • Excellent working knowledge and application of Current EU Guide to GMP and EU GDP
  • Good working knowledge of Quality Risk Management
  • Proven experience of supporting manufacture and packaging of solid dosage forms, liquids, creams, and sterile products
  • Proven experience of hosting and supporting Regulatory Inspections
  • Significant previous experience within Quality Assurance, creating or reviewing policies and procedures, internal auditing, reviewing deviations, change control requests, CAPA, etc.
  • Experience and confidence in managing teams, understanding of the difference between leadership and management
  • Excellent communication skills, both written and oral, and ability to forge good working relationships with internal and external customers
  • Calm, systematic, logical thinker, with ability to focus on priorities while coordinating multiple issues
  • Commitment to quality, patient safety, and achieving the best outcome with a pragmatic and strategic approach
  • Excellent time management skills
  • Positive attitude and flexible approach to work
What We Offer

We offer a competitive salary plus bonus and rewards package, including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme, and hybrid working.