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Senior QC Scientist

Job Title: Senior QC Scientist
Contract Type: Permanent
Location: Guildford, Surrey
Industry:
Salary: £30000 - £33000 per annum + company benefits
Start Date: April / May 2017
Reference: 69143-PHARM-JHY_1490887406
Contact Name: James Harvey
Contact Email: James.Harvey@volt.eu.com
Job Published: March 30, 2017 16:23

Job Description

Job title: Senior QC Scientist
Job type: Permanent
Location: Guildford, Surrey
Salary: £30,000 - £33,000 / year + company benefits

SUMMARY

*My client is a specialist pharmaceutical development company with an
enviable product range
*Due to exciting growth plans for 2017 they are looking to add an
experienced QC Scientist currently operating at a senior level
*The successful candidate would be working with a group of QC Scientists,
performing a range of clinical and stability studies

MAIN JOB PURPOSE

*Lead a group of QC scientists in performing clinical and stability
studies in compliance with SOPs and GxP guidelines including EudraLex Vol 4
and 2003/94/EC
*Author, review and approve QC / GxP documentation
*Provide training and guidance to other members of the QC team and
playing an active role in identifying and implementing process improvements

KEY DUTIES & RESPONSIBILITIES

*Lead a group of QC scientists in performing and delivering clinical and
stability studies in compliance with SOPs and GxP guidelines including
EudraLex Vol 4 and 2003/94/EC
*Liaise with Production, QA and Study Directors and plan QC resource
accordingly on existing and upcoming client projects
*Liaise with QC scientists and provide a schedule for the QC workload
*Carry out probationary and annual performance reviews of QC Scientists and
outline objectives against personal training plans
*Author, review and approve QC / GxP documentation according to SOPs and GxP
guidelines (includes but is not limited to specifications, certificate of
analysis, protocols, methods, SOPs, laboratory notebooks, chromatographic
data, study reports)
*Raise, execute and approve Quality Records including laboratory
investigations (OOS/OOT), deviations, CAPAs and Change Controls in a timely
manner
*Assist with all analytical testing against specifications, protocols,
methods and GMP guidelines and promptly record all data as per SOPs
*Ensure and promote data integrity in the QC team
*Adhere to SOPs at all times
*Provide training and technical input to other members of QC wherecompetent
and considered a subject matter expert
*Assist in the smooth running of the QC laboratories in line with GxP
guidelines and the upkeep and maintenance of laboratory equipment in line
with validation policy and plans
*Adhere to Health &Safety policy and COSHH regulations at all times and
ensure the safety of others in any procedures or tasks performed
*Ensure that all QC documentation, computer data and records are completed
and stored appropriately in accordance with SOPs and data integrity best
practices
*Assist the Head of Quality Control and other managers in gathering metrics
and identifying and implementing process improvements in accordance with
ICH Q10 and EudraLex Vol 4
*Participate in internal meetings, client meetings and telephone conferences
on behalf of the Head of Quality Control
*Liaise, manage and collaborate with suppliers and contractors when required
*Actively adhere to the personal training plan and continue personal
professional development with role

CANDIDATE SPECIFICATIONS

*Educated to degree level or equivalent in a scientific discipline
*Strong experience working in a similar capacity within the pharmaceutical
industry
*GMP-orientated individual with a strong demonstrable understanding of the
associated processes and principles
*Strong QC experience to include clinical batch release, stability studies,
deviations & CAPAs
*QC troubleshooting experience

PERSONAL ATTRIBUTES

*Motivated & driven individual who is happy to challenge existing
processes / procedures and suggest alternatives
*Someone who is looking to develop their career further and potentially step
into a mentoring role over time