IMQC Laboratory Analyst

Job description

Details:

We are a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing close to 100,000 people globally, we have 87 manufacturing sites around the world.
Our pharmaceuticals business researches, develops and makes available medicines that treat a variety of serious and chronic diseases. We have medicines available or in development in a wide range of areas including:
• infectious diseases
• cancer
• epilepsy
• heart disease
• asthma and chronic obstructive pulmonary disease
• HIV/AIDS

Ware Manufacturing Site:
Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in these dose forms, many of which are life saving medicines. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products. This must be achieved whilst consistently delivering outstanding quality, service and value to our patients.

Job Purpose:
The Quality Assurance department independently ensures that all aspects of the manufacture of products are performed in a controlled manner and meet commitments to international regulatory bodies as well as the requirements of current Good Manufacturing Practice. The laboratories, working as part of the Site Value Streams, will assure that manufactured products are compliant and fit for purpose. Specifically, the Incoming Materials Quality Control Laboratory provides assurance that all raw materials and packaging components used in the manufacture of products are suitable for their intended use.

Key responsibilities:
• Provides proficient service in the analysis of samples and supports technical investigations/monitoring, utilising a range of analytical techniques including chromatography, pharmacopoeial and physical property tests.
• Assists Laboratory Team Manager in overseeing the execution of batch/job testing and release, typically for one testing group. Provides guidance and support to Analysts, enabling efficient batch/job testing and release.
• Prepares and checks analytical data accurately according to company, customer and regulatory requirements.
• Verifies the quality and accuracy of analytical results and determines if material meets pre-defined acceptance criteria.
• Takes a lead role in batch/job approval process.
• Is responsible for assigned items of Laboratory equipment and instrumentation or 5S standards. Is an expert user, resolving issues and promoting best practices.
• Takes a lead role in provision of training for new starters and for Analysts in areas of expertise.
• Is responsible for the safety of self and others within the Laboratory.

Customer:
• Analyses samples according to pre-defined test methods, specifications or Pharmacopoeia. Ensures analytical records are accurate, clearly laid-out, legible, and recorded at the time of the task.
• Communicates progress on tasks and may provide updates on project progress to team or cross-functional meetings.
• Approves batches/jobs, ensuring all documentation is complete, accurate and the material is suitable for intended use.
• Undertakes complex analytical tasks, such as the planning, execution and reporting of analytical studies.

Cost :
• Provides guidance to Analysts to ensure efficient execution of testing plans.
• Is responsible for ensuring that Laboratory work areas maintain high standards of housekeeping and meet requirements such as 5S.
• Ensures own work is right the first time (RFT). Shares best practices to aid others in improving RFT performance.

Compliance:
• Maintains Laboratory equipment as assigned by Team Manager. Provides practical and theory training in the use of equipment and other areas of expertise.
• Checks analytical data/worksheets for accuracy and compliance and ensures correct methodology has been used.
• Ensures documents associated with own areas of responsibility, such as equipment records, are current and audit ready at all times. All documents and analytical reports are accurate, clearly laid-out, legible, and recorded at the time of the task.
• Responsible for ensuring equipment used is calibrated, validated and fit for use. Deficiencies are resolved promptly.
• Analysis is undertaken safely and compliantly, meeting all required standards of EHS legislation and GMP, such as COSHH, Risk Assessments and DSE.
• Responsible for documenting and communicating Laboratory issues, such as safety, compliance and analytical issues giving rise to invalid data.
• Ensures sample solutions, standards and test media are used within expiry dates, or re-evaluated as appropriate
• Is competent in change control processes. Ensures all relevant documentation is prepared and training is provided where required.

People:
• Writes procedures for the use of analytical equipment and to describe Laboratory ways of working. Provides suitable training where required to adopt new practices.
• Responsible for own training and development. Maintains up to date training records and performance and development plans. Identifies requirements for further training as required to support areas of responsibility.
• Will take a lead role in training of newly recruited Analysts.
• Proactively provides feedback on the quality and effectiveness of training as it is received.
• Ensures analytical knowledge and access to systems is up to date for all relevant equipment and techniques, and will seek refresher training as required.

New Products:
• May participate in method transfers and new product introduction exercises, for example, trialling new technology and methodology, providing feedback to Team Manager and other staff.

Applicants must demonstrate in their application how they meet the above criteria in order to be successful for interview selection.

When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.

Thank you for your interest in this opportunity.

The closing date for applications is Sunday 26th June 2016.

Contact information:

You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:

• Is highly proficient in key analytical skills including laboratory instruments, software packages and other analytical techniques. May have specialised expert knowledge in one or more analytical disciplines, such as Particle Sizing, IR, Pharmacopeial Testing, GC, HPLC or UV.
• Is proficient in problem solving and troubleshooting analytical equipment.
• Is competent in application of statistical and mathematical tools and formulae, and can derive formulae for analytical methods from first principles.
• Understands purpose of all techniques applicable to Raw Materials testing.
• Is aware of relevant national/international Pharmaceutical regulatory authorities.
• Is competent in the use of basic Lean Sigma tools, and can lead “JDI's”, and aware of the Quality Management System and 6 management principals.
• May have experience of equipment or method validation.

Preferred qualifications:

As above