Posted to MedZilla on 8/19/2017


ProClinical

England, QA Officer, Pharmaceutical QA_OB_13002-MZ


 
 

This attractive QA Officer, Pharmaceutical job is a great opportunity to join one of the pharma industry's biggest and most prestigious organisations. The company is located in South London and has been working for over a 150 years across multiple therapy areas including cardiovascular, neurology and immunology. The QA Officer role will provide day-to-day assistance for the compilation and completion of Annual Product Quality Reviews.The QA officer will ensure assigned tasks are performed in a timely manner to meet all associated international GMP/GDP requirements

Job Responsibilities

  • You will be responsible for conducting your activities to a high standard of business ethics and in compliance with the laws and regulations that govern GMP activities.
  • Takes personal responsibility for and demonstrates a high level of understanding of and adherence to the applicable internal policies, including but not limited to our Code of Ethics and Business Conduct and other policies applicable to this role, and external laws and regulations governing your activities.
  • Exhibits high business ethics standard in dealing with internal and external stakeholders, including dealing with others honestly and openly, showing accountability, and being reliable and trustworthy.
  • Completes all required compliance and GMP training within required timelines.
  • Encourages a high level of understanding of and adherence to compliance and ethics amongst colleagues and third parties.
  • Fully co-operates in any internal and external audits, investigations and inspections
  • Annual Product Quality Reviews i. To compile & review document sets for completeness & compliance to EU GMP and company internal requirements. ii. Notifying line manager of any potential compliance issues identified during compilation of APQRs, such as; manufacturing, testing, packaging and supply chain issues. iii. To complete all relevant documentation to support the QP in the release of drug products iv. Assisting with metrics and data analysis of APQR activities.
  • QA Support (Quality Systems) i. To be able to extract and interpret information from company internal quality systems including deviations/exception reporting, change control, supply agreements, complaint handling, quality metrics reporting, temperature excursion resolution, document control and retention systems, training as determined by the QA Manager. ii. Project execution and support as required.

Skills and Requirements:

  • Bachelor's degree in a related scientific discipline or equivalent relevant experience (Preferably Biology/ Chemistry/ Pharmacy/Life Sciences)
  • Basic experience in pharmaceutical manufacturing, distribution and control measures
  • Basic experience in Quality administered systems is preferred.
  • 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 (SOPs).
  • Quality and process orientation and mindset
  • Possession of excellent verbal and written communication skills
  • Ability to accept responsibility and be pro-active within defined limits
  • Excellent office skills - Word and Excel essential
  • Enthusiastic, positive individual driven to meet targets and standards 
  • High level of self- integrity and ethical conduct
  • Biotechnology / Biologics / Sterile injectable manufacture
  • Manufacture of novel dosage forms
  • Secondary / outsourced packaging activities
  • Global manufacture and supply chains

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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