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QA Associate

QA Associate

Job Title: QA Associate
Contract Type: Contract
Location: Dartford, Kent
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: QA01_1495460840
Contact Name: Alex Young
Contact Email: a.young@sciproglobal.com
Job Published: May 22, 2017 14:47

Job Description

  • Responsible for adherence and management of quality systems mainly related to product quality in line with cGMP's and current standard as part of the overall QMS.
  • Responsible for the continuous support to Operations activities in line with regulatory & compliance

Responsibilities

  1. To be responsible for the individual batch record review and release by supervising the activity of pre-contract review (SOW) and the review of manufacturing and QC test data.
  1. To support operations in inspecting equipment, releasing equipments, releasing incoming materials, reviewing data and generally any support task that Operations require to continue Production
  1. To ensure, together with QMS Manager that procedures and processes are followed in line with the Quality Manual.
  1. To ensure that the services provided meet all regulatory requirements and also client quality technical agreements.
  1. To support, assure and advice New Product Introduction into the facility in line with cGMP's requirements.
  1. To safeguard the quality of materials and data handled or processed in accordance with regulatory and cGMPs requirements.
  1. Ensure all facilities, systems, equipment, operations and data etc. are all time validated in accordance with c.GMP standards and industry expectations.
  1. To conduct investigations relative to complaint, liaise with the customer, participate in the CAPA implementation
  1. To conduct investigations relative to a deviation and OOS.
  1. Assure trending and management of complaints, deviations and KPI's affecting product quality when required.
  1. Generate any specific documentation or controlled document necessary in Operations for validation, sampling, etc…

Technical Skills/ Experience

  • Senior QA professional with extensive QA experience in batch review
  • Extensive experience of working in an API /Drug product manufacturing site and GMP environment
  • BD in scientific matters

Other Skills/ Experience

  • Ability to organise and prioritise work and display an accurate and systematic approach to work.
  • Ability to work under pressure to meet tight and changing deadlines.
  • Ability to be assertive to ensure appropriate GMP and business standards are achieved.
  • Ability to work unsupervised, be self-motivated and take the initiative to introduce new ideas.
  • Must be customer orientated with good written and verbal communication skills.
  • Must be able to make decisions in a timely manner.
  • Honesty and integrity, with a positive attitude to work.
  • Able to create and manage relationship cross-functionally
  • Thorough knowledge of EU, US and other regulations relevant to our operations as well as a strong working knowledge of API manufacturing.
  • High level of proficiency in computer skills, including publishing tools, databases, word processing, project and spreadsheets.

Business Environment:

  • Performance driven and customer focused.
  • Collaborative and inclusive.

Attitude:

  • Shows personal drive and self motivation
  • Able to work with minimum supervision and to a high standard
  • Comfortable working collaboratively as part of a small team and also able to influence others
  • Results orientated.
  • Positive, flexible and approachable.