Torbay and South Devon NHS Foundation Trust

Stability Lead Analyst

Information:

This job is now closed

Job summary

We have an exciting opportunity for you to join a small Stability team based in a Quality Control Laboratory You will be apart of a team who put together and perform stability trials of pharmaceutical products manufactured here at Torbay Pharmaceuticals.

We are looking for a lead analyst to support with the preparation and running of annual commitment batch studies and to assist with leading our established team to perform high quality analytical testing to cGMP standards to assure the Quality, Safety and Efficacy of our products across their shelf life. The role will contribute to ongoing annual testing of Licensed TP Products, in addition to playing a vital part in providing Stability data for the regulatory submission of new products across the globe.

Main duties of the job

  • Performing analysis of stability samples to meet the required standards in compliance with regulations.
  • Producing data to assist in the licensing of products for Torbay Pharmaceuticals and maintaining compliance.
  • Ensure that the stability programme is followed and that all data is generated to cGMP and the Pharmacetical Quality System
  • Ownership for writing annual commitment stability protocols, requesting samples and set-down.
  • Create data summary tables and update with results as required.
  • Undertaking investigations for out of specification and deviations ensuring compliance to cGMP within agreed timescales.

About us

Torbay Pharmaceuticals - Built by the NHS, Supplying the World

At Torbay Pharmaceuticals you'll work for a truly unique organisation and alongside the most committed people in the business. We have ambitious plans to grow our business over the next few years and we know that we can't do that without everyone playing their part. That's why we believe in theOne TPway of working.

Shared responsibility for getting a job done is core to our values and is underpinned by aWe can if...attitude. If one team needs help to meet a goal, then the rest of us pitch in to help. It's just what we do and we only want to work with others who would do that too.

Details

Date posted

17 May 2023

Pay scheme

Agenda for change

Band

Band 5

Salary

£28,407 to £34,581 a year per annum,

Contract

Permanent

Working pattern

Full-time

Reference number

388-5282457-TP

Job locations

Torbay Pharmaceuticals

Wilkins Drive

Paignton

TQ4 7FG


Job description

Job responsibilities

Full details can be found on the attached Job Description. In your application please refer to the person specification/role requirements in your supporting information

Job description

Job responsibilities

Full details can be found on the attached Job Description. In your application please refer to the person specification/role requirements in your supporting information

Person Specification

Qualifications

Essential

  • Honours degree in Chemistry or related subject

Desirable

  • Leadership qualification

Experience, Knowledge and Skills

Essential

  • Post qualification experience in analytical chemistry.
  • Experience of working to a Pharmaceutical Quality System. (GMP, ISO, etc)
  • Experience in HPLC and associated software.
  • Knowledge of the sampling, testing and reporting of analysis performed on Pharmaceutical finished products, cleaning and process validation samples.
  • Knowledge of British, European and United States pharmacopoeias.
  • Ability to problem solve in pharmaceutical analysis
  • Knowledge of Laboratory Health and Safety and COSHH.
  • Ability to use several different specialised computer software systems that control laboratory equipment plus traditional packages such as Word/Excel
  • Detailed knowledge of ICH Guidelines Q1A-Q1F

Desirable

  • Writing User requirement specifications and undertaking IQ, OQ and PQ in order to implement new pieces of equipment.
Person Specification

Qualifications

Essential

  • Honours degree in Chemistry or related subject

Desirable

  • Leadership qualification

Experience, Knowledge and Skills

Essential

  • Post qualification experience in analytical chemistry.
  • Experience of working to a Pharmaceutical Quality System. (GMP, ISO, etc)
  • Experience in HPLC and associated software.
  • Knowledge of the sampling, testing and reporting of analysis performed on Pharmaceutical finished products, cleaning and process validation samples.
  • Knowledge of British, European and United States pharmacopoeias.
  • Ability to problem solve in pharmaceutical analysis
  • Knowledge of Laboratory Health and Safety and COSHH.
  • Ability to use several different specialised computer software systems that control laboratory equipment plus traditional packages such as Word/Excel
  • Detailed knowledge of ICH Guidelines Q1A-Q1F

Desirable

  • Writing User requirement specifications and undertaking IQ, OQ and PQ in order to implement new pieces of equipment.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Torbay and South Devon NHS Foundation Trust

Address

Torbay Pharmaceuticals

Wilkins Drive

Paignton

TQ4 7FG


Employer's website

https://www.torbayandsouthdevon.nhs.uk (Opens in a new tab)

Employer details

Employer name

Torbay and South Devon NHS Foundation Trust

Address

Torbay Pharmaceuticals

Wilkins Drive

Paignton

TQ4 7FG


Employer's website

https://www.torbayandsouthdevon.nhs.uk (Opens in a new tab)

Employer contact details

For questions about the job, contact:

Stability Specialist

Jess Frost

jessica.frost7@nhs.net

01803660017

Details

Date posted

17 May 2023

Pay scheme

Agenda for change

Band

Band 5

Salary

£28,407 to £34,581 a year per annum,

Contract

Permanent

Working pattern

Full-time

Reference number

388-5282457-TP

Job locations

Torbay Pharmaceuticals

Wilkins Drive

Paignton

TQ4 7FG


Supporting documents

Privacy notice

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