Quality Assurance Officer

CK Group are recruiting for a Quality Assurance Officer to join a company in the Pharmaceutical industry at their site based in Marlow on a contract basis for 6 months.
Salary:
PAYE up to max £16.63 per hour
Umbrella up to max £18.64 per hour
Company:
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.
Location:
This Quality Assurance officer role will be based at our clients site in Marlow.
Quality Assurance officer Role:
Primary Duties:
Batch Release

• To compile & review batch document sets for completeness & compliance to EU GMP, internal requirements and regulatory dossier submissions.
• To resolve manufacturing, testing, packaging, and supply chain issues to support batch disposition.
• To complete all relevant documentation to support the QP in the release of drug products To assist the certifying QP in the release of the drug product where required within client systems.

QA Support (Quality Systems)

• To assist in maintenance of quality systems including complaint handling, deviations/exception reporting, change control, supply agreements, document control, complaint handling, quality metrics reporting, temperature excursion resolution, document control and retention systems, training as determined by the Quality Manager.
• Project execution and support as required.

Your Background:
Training & Education Required:

• Bachelor’s degree in a related scientific discipline with relevant experience (Preferably Biology/ Chemistry/ Pharmacy/ Life Sciences)
• Basic experience in pharmaceutical manufacturing, distribution, and control measures
• Basic experience in Quality administered systems. Previous use of TrackWise® QMS beneficial.
• Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
• Able to demonstrate good planning and organisation skills.
• Attention to detail and accuracy – able to follow verbal and written instruction (SOP’s).
• Quality and process orientation and mindset
• Possession of good verbal and written communication skills
• Ability to accept responsibility and be pro-active within defined limits Excellent system skills – Word and Excel essential, experience with electronic documentation control systems advantageous.
• Enthusiastic, positive individual driven to meet targets and standards.
• High level of self- integrity and ethical conduct

Training & Education Preferred:

• Sterile injectable manufacture Manufacture of novel dosage forms
• Secondary / outsourced packaging activities Global manufacture and supply chains
• New product launches & commercial supply chain

Prior Experience Required:
Experience from a science-based job role
Prior Experience Preferred:
2-3 years in a GMP environment
Technical Competencies Required:
Scientific

• Experience in operating in a QMS.
• Experience in writing deviations, change controls, CAPAs, complaints.
• Experience in supporting internal and external audits including BOH inspections.
• Knowledge of API manufacture, primary compounding, primary and secondary packaging and release, preferred.
• Knowledge in validation of facilities, utilities, equipment, processes, analytical methods
• Knowledge of GMP & GDP
• Ability to apply technical knowledge in day-to-day activities and quality system records
• Knowledge of Manufacture of solid dosage forms
• Knowledge of manufacture of sterile medicinal products
• Knowledge of Microbiology or chemistry laboratory testing methods

Technical Competencies Preferred: Scientific

• Manufacture of solid dosage forms
• Secondary/ outsourced packaging activities
• Global manufacture and supply chains

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56474 in all correspondence.