Skip to main content

This job has expired

Senior Quality Assurance Coordinator

Employer
i-Pharm Consulting
Location
Australia, Victoria, Melbourne
Salary
Negotiable
Start date
7 Jun 2021
Closing date
21 Jun 2021

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

ROLE/DESCRIPTION

  • CA/PAs and investigations into non-conformance
  • Change Control process management and risk assessment
  • Customer Complaints and product complaints register maintenance with regulatory support
  • Ongoing review of Quality indicators and preparation of Quality Scorecards/Quality Management Review meeting
  • Assist with Supplier Approval process, audits, and ongoing review of suppliers and contractors
  • Document management and QMS compliance with relevant regulatory requirements
  • Validation activity review, approval and compliance with QMS requirements such as ISO, ICH, CFR, GAMP
  • Perform QA raw material release activities, reviewing Batch Process Records, QC release testing, labelling requirements in accordance with defined manufacturing timelines
  • Review/update the QMS Training Matrix collaborate with department managers maintain appropriate training and performance within QMS
  • Support QA Director during audits
  • 2nd in charge to QA Management and additional responsibilities when required
  • Collaborate with team members and external stakeholders.
  • Review documentation to ensure it is current and QMS compliant.

REQUIREMENTS

  • Minimum degree qualification in biomedical/biotechnology, science, engineering or similar
  • At least 4 years' experience in a QA role for medical devices or organisation regulated by ISO13485 and/or GMP/21CFR820
  • Computerised System Validation experience is desirable
  • ISO13485 and GMP quality systems knowledge
  • ISO9001 or ISO13485 auditor certified (Lead Auditor qualification preferable)
  • Good understanding of ISO14971 risk management in a manufacturing environment
  • Able for occasional flexible work outside of normal working hours.
  • Ability to travel for audits and training.

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Recruitment Consultant, Rachel Jennings on +61 (0) 2 8310 5846, or email rjennings@i-pharmconsulting.com. If this role is not suitable, Rachel is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS

Senior Quality Assurance Associate, Quality Manager, Quality Director, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Regulatory Associate, Senior Regulatory Associate, Regulatory Manager, Submissions/Documentation, QMS, CAPA, ISO 13485.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

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

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

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.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert