QA Specialist

The Quality Assurance Specialist is responsible for maintaining the quality management systems, supporting production activities (including batch review), project support, oversight of material management and approval of materials/service providers, approval of validation documentation, audit support activities and other QA activities onsite. This is an onsite role Monday to Friday with flexible working hours.

Responsibilities

• Responsible for document review (batch documents, logbooks, protocols, SOPs, forms etc)
• Use Quality systems to ensure compliance (Documentation, Deviation, CAPA, Change control etc)
• Contributes to supplier quality assurance program and new supplier qualification
• Supporting and leading quality related investigations, writing investigation reports and initiating/following up on CAPAs
• Use, support and maintain training systems, training programmes and training documentation
• Proactive administration of the QMS, metrics/KPI management and trending for Quality
• Works closely with all functions and departments to ensure efficient document review according to CGMP
• Supports and leads in self inspections, customer and regulatory audits
• Support and lead other activities like data integrity activities, Quality Risk Management, approving pre and post execution validation documents
• Supporting batch release of clinical bulk drug substance
• Comply with all safety, health, and environmental requirements.

Key Skills and Competencies

• Minimum HND Biological subject and have a proven track record in QA in the pharmaceutical industry (or related industry)
• Minimum 5 years experience in a QA role within either pharmaceuticals or Biopharmaceutical environment.
• Experience of working within QC and/or manufacturing would be advantageous
• Knowledge and practical experience of GMP and GLP systems
• MHRA and other regulatory guidelines knowledge
• Ability to work under pressure and work accurately with attention to detail
• Ability to prioritise and deal effectively with a varied workload
• Experience of using Master Control would be advantageous
• Good communication skills with the ability to form strong working relationships with stakeholders at all levels across the organisation
• Competent with IT systems, particularly Microsoft Office including Outlook, PowerPoint, Word and Excel.

You will receive

• A competitive salary, pension scheme, private healthcare, retail discounts through reward gateway, cycle to work, 26 days annual leave and bank holidays, death in service coverage, on-site health and wellbeing support and medical consultation and physiotherapy, 24/7 employee assistance programme.
• Training and opportunities for further career development.

Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and Ireland, where we employ talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.

Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.

Be caring. Be transparent. Be willing. Be reliable.