Job Description Form QA Exec 2

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Job Description Form QA Exec 2 Powered By Docstoc
					                                                                           Job Description
 Unit Name                                           : Quality

 Job title (Designation)                             : QA Systems Executive

 Location                                            : Croydon

 Responsible to                                      : QA Systems Manager

 Overall Purpose:

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
training databases.



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
   Investigational skills
   Good use of written English
   Good communication skills
   Computer literate


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

				
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