Pharmaceutical QC Scientist

Job description

Job responsibilities

Main Duties and Responsibilities

To work at all times in accordance with the requirements of the Quality Manual, Good Laboratory Practice and UKAS. All testing must be performed in accordance with established procedures to assess compliance with approved specifications. To perform routine chemical testing on raw materials, in-process samples, finished pharmaceutical products and environmental samples. To perform quantitative and semi-quantitative analysis of pharmaceutical clean down wipes from a range of pharmaceutical and environmental origins using the LC/MS . To perform method validation work, and prepare validation reports for all analytical techniques as directed by senior staff and laboratory procedures. To undertake validation studies and research projects under the direction of your line manager. To perform equipment calibration checks and maintenance as directed by laboratory procedures. To maintain reagent stocks within the laboratory. To maintain the laboratory environment in an appropriate condition, including the clean down of surfaces and cabinets and the safe disposal of laboratory waste. To keep accurate records of all work performed.

Communications

To participate in Section and departmental staff meetings. To communicate with other team members so as to ensure the efficient use of equipment and the timely testing of samples. To communicate difficulties to senior staff in order to minimise delays. To communicate verbally or in writing, out-of-specification test results to clients including Production and Aseptic Unit staff, in the absence of laboratory signatories. To deal with telephone enquiries from clients, ensuring that the query is passed on to the appropriate person where no answer can be given.

Responsibility for Patient Care Helping to ensure medicines prepared by Pharmaceutical Production Units and Aseptic Suites across the North West, meet statutory requirements for occupational safety. To perform routine chemical testing on raw materials, in-process samples, finished pharmaceutical products and environmental samples. To perform quantitative and semi-quantitative analysis of pharmaceutical clean down wipes from a range of pharmaceutical and environmental origins samples using the LC/MS . To perform method validation work, and prepare validation reports for all analytical techniques as directed by senior staff and laboratory procedures. To ensure correct evaluation of data and production of laboratory reports for submission to the releasing officer. To work to predetermined time scales ensuring timely release of products.

Planning and organising

To plan own work on a day-to-day basis, ensuring that the service is delivered in accordance with contracted turn-round times.

Responsibilities for Physical and / or Financial Resources

To initiate the order of laboratory reagents and other consumables in order to maintain stocks. To maintain, calibrate and ensure the correct use of expensive laboratory equipment.

Responsibility for Policy and Service Development and Implementation

To make suggestions in Section and departmental staff meetings. To operate at all times in accordance with departmental policy and procedures.

Responsibilities for Human Resources and Leadership

To participate in peer checking programme (after probationary period, usually 6 months).

Responsibilities for Teaching and Training

To be involved in the training of new or junior staff.

Responsibilities for data and information resources

To maintain accurate records of analytical work in accordance with Good Laboratory Practice. To process analytical data, performing mathematical calculations (including statistics) to determine compliance with specifications. To perform data entry of large numbers of environmental test results onto the LIMS To prepare routine laboratory reports using LIMS for approval by laboratory signatories. To prepare complex validation or calibration reports using Microsoft Word for approval by your line manager.

Research, Development and Audit

To carry out a broad range of chemical tests on starting materials, packaging components environmental samples and pharmaceutical products to ensure they are fit for use. To be involved in Research and Development projects, performing work under the direction of your line manager. To participate in laboratory internal and external audits and take responsibility for corrective and preventative actions as required.

Physical Skills and Effort Some light lifting and moving duties are included. VDU work.

Person Specification

Education and Qualifications

Essential

• Degree in Chemistry or closely related subject

Desirable

• Analytical specialisation

Knowledge

Essential

• Knowledge of broad range of classical and instrumental analytical techniques
• Knowledge of principles of GLP, laboratory H&S and COSHH
• Knowledge pharmaceutical analysis

Experience

Essential

• Analytical experience eg. during training

Desirable

• Work in a laboratory operating to similar standards of GLP/UKAS
• Familiarity with pharmacopoeias
• Use of LIMS system

Skills & Abilities

Essential

• Excellent analytical skills
• Excellent manual dexterity
• Numeracy
• Good record keeping
• Good team worker
• Ability to work without direct supervision
• Keyboard skills
• Time management

Work Related Circumstances

Essential

• Good general health

Desirable

• Flexible to cover occasional out of hours working
• Willingness to work off site
• Able to use own car for off-site work

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Stockport NHS Foundation Trust

Address

Quality Control North West - Stepping Hill Hospital

Poplar Grove

Stockport

SK27JE

Employer's website

http://www.stockport.nhs.uk/ (Opens in a new tab)