Quality control Specialist (System intergration)

Employer
i-Pharm Consulting
Location
Republic of Ireland, Carlow
Salary
£54.22 - £58.73 per hour + 12.5 days holiday + Any holidays paid
Closing date
30 Sep 2020

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Contract
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Overview

DURATION - 6 MONTHS.

To provide technical knowledge and complete the execution for the integration of Laboratory instruments with other systems such as LIMS while ensuring the continued manufacture and supply of quality pharmaceutical products in meeting the Manufacturing Division priorities of: Compliance, Supply, Strategy and Profit Plan.

Principal Accountabilities:

  • Management of Lab projects for instrument integration from end to end including the physical execution of the project requirements
  • An efficient support to all departments at Client site including QC Microbiology, Quality Control and Quality Operations lab for issues pertaining to LIMS and Instrument integration and to be a subject matter expert for these areas.
  • Deliver training to all employees on the integrated systems.
  • Development and testing of LIMS static data builds. Create LIMS static data standard in relation to instrument integration
  • Provide technical support to all users at Client Site. Liaise with Global systems working groups.
  • Ensures data integrity requirements is incorporated and verified through the project implementation.
  • Represent Client in relation to Laboratoy systems and implementation in conjunction with global teams.
  • Management of system Change Controls.
  • Provide subject matter expertise in relation to Laboratory Systems.
  • Actively identifies and progresses continuous improvement opportunities. Ensures strict adherence to site policies/procedure and good manufacturing practices.
  • Coach and guide colleagues onsite and in the network on the use of Laboratory Systems.
  • Interpret customer needs, assess requirements and identify solutions to non-standard requests.
  • Ensure highest safety standards.
  • Required to comply with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Acts a LIMS Site Administrator providing support to the relevant departments to ensure LIMS builds are created in accordance with product/ material testing schedules.
  • Performs assessments and provides overview of systems from a data integrity perspective ensuring the highest standards are maintained.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

Core Competences:

Technical:

  • Excellent knowledge and experience of LIMS and Lab Instrumentation.
  • Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
  • Empower knowledge and experience is desired
  • Proficiency in Microsoft Office and job related computer applications required
  • Laboratory Quality System
  • Report, standards, policy writing skills required

Business:

  • Understand the specific responsibilities of all Client departments as they relate to one's own department, understanding the business processes ones department supports
  • Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
  • Planning and scheduling skills
  • Decision Making Strategy development
  • Demonstrable analytical and systematic problem solving
  • Proven organizational skills
  • Starter/Finisher
  • Self-motivated
  • Effective time management and multi-tasking skills
  • Excellent attention to detail
  • Trouble shooting skills
  • Goal/results orientated
  • Data analysis
  • Training skills

Life Sciences recruitment is what we do.

We are an award-winning international life sciences recruitment company with offices in London, New York, Munich, Singapore and Sydney.  In a highly competitive market-place, we connect top talent with the very best opportunities.

 

Our clients include many of the most successful and innovative Pharmaceutical, Biotechnology, and Medical Devices companies, as well as a range of Contract Research & Manufacturing Organisations, Healthcare Agencies and Consultancies.

 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

Contact Us
  • 212 New King’s Road
  • London
  • SW6 4NZ
  • GB
  • +44 (0) 20 3189 2299
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