Quality Technical Administrator

Quality Technical Administrator
Norgine, United Kingdom

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
High School or equivalent
Total Vacancies
1 Job
Posted on
May 3, 2021
Last Date
Jun 3, 2021
Location(s)

Job Description

MAIN PURPOSE

To support Quality Assurance and carry out key responsibilities within Quality Assurance as listed below.

KEY RESPONSIBILITIES amp; ACCOUNTABILITIES:

  • Review batch documentation to ensure satisfactorily completed prior to batch certification by the QP or responsible person for Medical Devices.
  • To prepare, control, maintain and co-ordinate master documents in a timely and accurate manner, and to provide a service site wide/external clients
  • To provide appropriate Quality data to support Key Performance Indicators
  • Supply information for, coordinate execution amp; review of Product Quality Review process.
  • Creation of Quality Agreements for commercial partners
  • To support the ONE Norgine model particularly with regards the Global Quality
  • Maintain key quality documents, including, but not limited to, the site master file, inspection evidence files amp; Quality related SOPs.


MAIN TASKS

  • To manage and maintain the Batch Record Administration process and flow to aid batch record review and QP certification.
  • To perform batch review, as a delegated duty from the QP as part of the certification process.
  • To maintain an overview of quality compliance through the effective use of key performance indicators.
  • Reporting Quality related KPI’s to the site and globally.
  • Preparation of quality related documentation, including but not limited to the SMF, Quality SOPs training, monthly and quarterly reports.
  • Maintain the manufacturing site licences.
  • Work with SQO, QO amp; QM to manage documentation associated with the sites’ QMS, including, appropriate distribution, reporting and escalation.
  • The control of documentation required to support and control key systems.
  • General administration duties for Site Quality Department including typing, filing, logging, archiving, creation and issuance of documents as appropriate.
  • Issuance and filing Out of Specification reports, Change Controls, master copies of SOP’s, Customer Complaints and reject batches.
  • Issuance and filing of additional sheets as requested by operations departments.
  • Contact Norgine affiliates with QA complaint responses. Maintain database log, file, archive (with any returned samples) and issue reports.
  • Liaise with Regulatory Affairs and Associate Companies to provide samples of finished product, raw materials, packaging, Certificates of Analysis and any documentation requested.
  • Producing graphical representation of analytical data to support investigations and/ or product quality reviews.
  • Departmental training co-ordination including data entry of training briefing/schedules.
  • Supporting Technical Development clinical trial requirements as necessary
    • Review of clinical trial data/labels
  • Any other reasonable technical and/or administrative task required by the department.

RELATIONSHIPS:

Maintains excellent working relationships with all departments across Hengoed site.

Liaise with other manufacturing sites within Norgine and through the External Network Structure.

Requirements

SKILLS amp; KNOWLEDGE

  • A good standard of education with some relevant science knowledge or experience is desired. Formal qualifications in a science subject would be an advantage.
  • Experience within the Pharmaceutical Industry or in an Administrative position would be an advantage, but is not essential.
  • The job holder should be motivated, be able to work on their own initiative, or work as part of a team with excellent communication skills. The ability to adapt in a challenging environment is essential.
  • A working knowledge of Quality and GMP guidelines would also be an advantage.
  • High attention to detail is essential, along with the ability to write procedures, and the capability to check mathematical calculations.
  • Computer literate and able to use standard Norgine defined software

Benefits

Company pension scheme

Salary sacrifice schemes including buying of holidays, cycle to work etc..

Private health scheme

Employee Assistance Programme

25 days holiday plus bank holidays

Increase in holidays for long service

A day leave for moving house and getting married

Flexible working

Discretionary company scheme

Free on- site parking

Job Specification

Job Rewards and Benefits

Norgine

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