quality manager in hallam

posted
job type
permanent
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job details

posted
location
hallam, victoria
job category
life sciences & pharma
job type
permanent
reference number
90M0340344_1526282925
phone
00 00
apply now

job description

To support company growth, my client are seeking a tertiary qualified, highly experienced Quality Control Manager to be part of their Senior Management Team. This role is fundamental to the success of the business moving forward thus you will be experienced in managing an entire QC/ QA team.

QUALIFICATIONS/EXPERIENCE

  • Relevant tertiary education
  • Pharmaceutical industry experience
  • Quality system management experience

DIRECT REPORTS

  • QC Team Lead, QA Officer, QA Officer/Document Controller, Validation Specialist

KEY AREAS OF RESPONSIBILITY

  • Ensure that the client Quality System is maintained in accordance with the requirements of PIC/S 2017
  • Working with the Plant Manager to ensure that the company maintains a satisfactory level of GMP compliance as determined by GMP audits

RESPONSIBILITIES/ACCOUNTABILITIES/AUTHORITIES

  • Review and approve all GMP related procedures, including the implementation of PIC/S 2017
  • Identify and propose improvements to the Quality System
  • Management of the Site Master File
  • Approve specifications, sampling instructions, master processing and packaging instructions and all in house and contract manufacturing procedures.
  • Ensure GMP documents and records are retained safely and securely for the specified time
  • Oversee/Manage the approval all suppliers of starting materials
  • Oversee/Manage all contract manufacturers and testing laboratories
  • Oversee/Manage the approval or rejection of starting materials, packaging, intermediates and finished product
  • Oversee/Manager the review and evaluate batch manufacturing records
  • Establish sampling and testing plans and ensure all specified testing has been carried out
  • Authorise release from manufacture and release for supply in accordance with Marketing Authorisations
  • Oversee and manage approval of Stability protocols and reports
  • Manage Stability program and ensure time points are met
  • Oversee and manage approval of Validation protocols and reports
  • Manage the Validation process and ensure time points are met
  • Ensure all initial and ongoing GMP related training is carried out
  • Manage the maintenance of major equipment register
  • Review product manufacturing and test results records to ensure adequate performance and control of manufacturing procedures.
  • Ensure GMP systems are audited (Internal Audits)
  • Manage Deviations & Out of Specifications, including investigations
  • Oversee corrective and preventative actions
  • Manage/Approve Change Controls and ensure Change Control system is effective
  • Manage Customer Complaints, including investigations
  • Oversee and Manage Risk Assessments
  • Ensure GMP and confidentiality agreements are in place, current and followed

If you believe you are suitable for this role, please apply in WORD format via the link below or give Samantha Lin a call on (03) 9590 2224 for a confidential chat.

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

skills

Senior Quality role

qualification

Tertiary degree qualified in science/ pharmaceuticals

educational requirements

Bachelor Degree