Unit Name : Quality
Job title (Designation) : QA Systems Executive
Location : Croydon
Responsible to : QA Systems Manager
To assist in maintaining the Quality Management System in accordance with cGMP and current
pharmaceutical industry standards. Assist in the management and maintenance of stability programme,
review and approve analytical development and validation reports, set up and maintenance of Quality
KEY RESULT AREAS (Core functional areas required to perform the job)
Provide support in the generation, production, control and distribution of SOPs and documents
within the Mercury Pharma QMS.
To assist in performing internal audits of Mercury Pharma processes and procedures
To assist in the management and maintenance of the stability programme.
To be a key point of contact with external suppliers and contract laboratories.
To ensure that technical agreements are in place and maintained for all suppliers.
To review and approve analytical development and validation reports from contract manufacturers.
To maintain and improve the quality training database.
ESSENTIAL QUALIFICATION (Relevant qualification):
A-level or equivalent in science based subject
DESIRABLE QUALIFICATION (Preferred qualification):
Life science graduate (chemistry / biology / pharmacy or close equivalent)
ESSENTIAL EXPERIENCE (Relevant experience/sector/role):
Held QC / QA position in pharmaceutical manufacturing / testing environment
DESIRABLE EXPERIENCE (Preferred experience/sector/role):
Has experience of working in a virtual company environment or similar
Has previous experience in customer-facing role
KNOWLEDGE AND SKILLS REQUIRED (e.g. Communication skill, Interpersonal skill):
Knowledge of GMP / QMS / QA and QC practices
Knowledge of manufacturing / testing practices
Good use of written English
Good communication skills
ROLES AND ACCOUNTABILITY (Job responsibilities):
To support the QA Unit in assuring Mercury Pharma continues to meet applicable quality standards.
To maintain technical agreements with all suppliers
To review and approve analytical and stability reports from suppliers and contract laboratories
To be key point of contact for contract laboratories
To perform self inspection audits of the Mercury Pharma QMS
Assisting in the change control assessment and disposition process
Review of batch manufacturing records and finished product samples
Provide support during inspections by competent authorities
Track, trend and report on quality KPIs and deliverables
Provide support to supply chain colleagues as required
To assist in promoting and advancing quality awareness throughout the Company