Job description

This is an exciting opportunity for a QA Specialist to join an expanding team in the analytical and microbiology laboratory in Dagenham, London.

This is a full time position. You must have the right to work in the UK.

Job Description

• Ensure activities performed by the QC department are performed in accordance with GMP, SOPs, pharmacopoeial requirements.
• Troubleshooting analytical issues and ensuring where appropriate that relevant quality incidents (deviations/OOS are raised) as per SOP
• Control and preparation of QA documents including SOPs, validation, transfer, change controls, CAPAs, deviations
• Support audits including MHRA, customer and Home Office inspections
• Review of analyst work, including analytical and microbiology
• Training of staff as and when required
• Preparation and control of methods of analysis and specifications
• Stability and analytical methods validation / verification and transfer protocols
• Review of spreadsheet validation protocols, reports and spreadsheets
• Equipment and software validation
• Ensure the laboratory meets GMP requirements at all times
• Coordinate activities between QC and QA departments to ensure KPIs, deadlines and expectations are met
• Ensure routine trending of results in the lab. Investigate OOS and OOT results, determine root causes and implement effective CAPA actions.
• Communicate with clients as and when required
• Perform annual training assessments to GMP and local SOPs
• Perform business continuity responsibilities, as and when required as per SOP026
• Use of LIMS
• Use of Eupry
• Use of Lab Solutions
• Develop Specifications and Standard Operating Procedures
• To uphold company procedures in regards to GMP and comply with UK pharmaceutical regulations at all times.
• Investigate customer complaints as per local SOPs, work with customers on resolutions of issues while ensuring GMP and customer service
• Keep up to date and advise the implications of legislative/regulatory changes to the business.
• Sign off on COAs
• Proactively contribute to creating a good team atmosphere
• Support the MD with client quotes/commercials and also billing from time to time

Performs all other duties as assigned.

Mandatory Candidate Requirements:

• Bachelor’s degree in sciences or related discipline
• Minimum 3 years’ experience working within QA in a GMP pharma environment.
• 3 years experience in HPLC, validation and transfer
• Experience with Scientific and/or Pharmaceutical terms.
• Experience working to GMP and related practices for the manufacture of active pharmaceutical products.
• Excellent Microsoft Office skills.

In return, the opportunities for personal and career development within the business are vast.

You will benefit from exceptional training and development opportunities, in addition to extensive cross-training within the business.

Aspire Laboratories provided the following inclusive hiring information:

We are an equal opportunity employer and considers all qualified applicants equally without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Job Types: Full-time, Permanent

QC, quality, control, assurance, analytical, micro, testing, solid, dose, raw materials, laboratory, analyst, GMP, manufacturing, HPLC, chromatography, GC, chemistry, development, validation, transfer

Job Types: Full-time, Permanent

Salary: £28,000.00-£35,000.00 per year

Benefits:

• Casual dress
• Company pension
• On-site parking

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Dagenham, Greater London: reliably commute or plan to relocate before starting work (preferred)

Education:

• Bachelor's (preferred)

Experience:

• QA in a GMP environment: 3 years (required)
• HPLC (from industry only, not university): 2 years (required)

Work Location: In person