Job Description

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Quality Assurance Manager

Advertiser: Lipa Pharmaceuticals LtdMore jobs from this company

Job Information

Job Listing Date
8 Mar 2019
Location
Sydney, South West & M5 Corridor
Work Type
Full Time
Classification
Manufacturing, Transport & Logistics, Quality Assurance & Control

Quality Assurance Manager

Lipa Pharmaceuticals Limited is a contract manufacturer of pharmaceutical/complementary products in the Campbelltown area of Sydney. The organisation has a number of Australian and overseas leading brands as customers, with multiple processing sites in Sydney and Melbourne.

With increasing regulatory compliance requirements (locally and overseas), we are looking for Quality Assurance leader with solid working experience in the pharmaceutical, complementary and/or complex food manufacturing organisations. Applicants with 'hands on' knowledge of the PICS and FDA codes for pharmaceutical manufacturing will have a definite advantage. This will be one of two senior QA roles that will be servicing the overall Group.

Reporting directly to the Chief Quality Officer, you will need to be able to drive and deliver the following operational and business unit requirements:

  • Ensure compliance to internal SOP’s, Policies and the PICS code requirements
  • Ensure all activities for product release are in line with regulatory requirements
  • Oversight and or management of raw and active material release activities, across business units
  • Oversight and or management of all QC and Microbiology testing processes to ensure compliance
  • Scheduling, maintaining  internal and external audit schedules across business units
  • Working with requisite internal and external service providers to identify and introduce new eQMS and LIMS systems across business units
  • Working with the CQO and key senior management teams to develop and upskill internal and external quality resources to meet existing and future business unit requirements
  • Work with the groups, middle and senior management teams to continuously nurture and develop an organisation wide culture based on best practice, global levels of customer service, quality and competitiveness.
  • Work with internal sales and commercial teams to ensure the highest levels of support, proactive communication and compliance with our key customer base.
  • Work with our local TGA and overseas regulators to ensure our own compliance as well as assist our customers in terms of their compliance requirements where it is sought and required.

The successful candidate will possess the following requirements and attributes:

  • Tertiary qualifications in Sciences (Chemistry) and or Pharmacy (and or similar).
  • Hands on experience and knowledge of the PICS and or the FDA codes for pharmaceutical manufacturing
  • Experienced in large scale operations with established quality systems
  • Direct experience and or substantial exposure to mainstream eQMS and LIMS systems
  • Experienced in high performance laboratory procedures and/or laboratory management processes
  • Well developed and practical people management and leadership skills
  •  Excellent verbal and written communication skills
  • Excellent mainstream ERP and general computer skills 
  • Keenly analytical and highly driven, strong personality with high levels of people empathy
  • An exceptional capacity to multi task and work under tight deadlines in a highly dynamic and proactive environment.
  • Exceptional negotiating and people management and directing skills
  • A street smart operator, able to lead, manage , direct and influence those around him with a strong formal technical background and ability to absorb and utilize new sources of information effectively and efficiently.
  • A person looking to achieve and continuously grow rather than just do a 'job'.

 If you believe you are the right person for the above role – we offer a very competitive and negotiable salary for the right person as well as an opportunity to continue to progress in terms of more senior career opportunities.

Please note: The successful candidate will be required to undergo Police, medical, reference and psychometric testing.
 

www.lipa.com.au

Lipa Pharmaceuticals Limited is a contract manufacturer of pharmaceutical/complementary products in the Campbelltown area of Sydney. The organisation has a number of Australian and overseas leading brands as customers, with multiple processing sites in Sydney and Melbourne.

With increasing regulatory compliance requirements (locally and overseas), we are looking for Quality Assurance leader with solid working experience in the pharmaceutical, complementary and/or complex food manufacturing organisations. Applicants with 'hands on' knowledge of the PICS and FDA codes for pharmaceutical manufacturing will have a definite advantage. This will be one of two senior QA roles that will be servicing the overall Group.

Reporting directly to the Chief Quality Officer, you will need to be able to drive and deliver the following operational and business unit requirements:

  • Ensure compliance to internal SOP’s, Policies and the PICS code requirements
  • Ensure all activities for product release are in line with regulatory requirements
  • Oversight and or management of raw and active material release activities, across business units
  • Oversight and or management of all QC and Microbiology testing processes to ensure compliance
  • Scheduling, maintaining  internal and external audit schedules across business units
  • Working with requisite internal and external service providers to identify and introduce new eQMS and LIMS systems across business units
  • Working with the CQO and key senior management teams to develop and upskill internal and external quality resources to meet existing and future business unit requirements
  • Work with the groups, middle and senior management teams to continuously nurture and develop an organisation wide culture based on best practice, global levels of customer service, quality and competitiveness.
  • Work with internal sales and commercial teams to ensure the highest levels of support, proactive communication and compliance with our key customer base.
  • Work with our local TGA and overseas regulators to ensure our own compliance as well as assist our customers in terms of their compliance requirements where it is sought and required.

The successful candidate will possess the following requirements and attributes:

  • Tertiary qualifications in Sciences (Chemistry) and or Pharmacy (and or similar).
  • Hands on experience and knowledge of the PICS and or the FDA codes for pharmaceutical manufacturing
  • Experienced in large scale operations with established quality systems
  • Direct experience and or substantial exposure to mainstream eQMS and LIMS systems
  • Experienced in high performance laboratory procedures and/or laboratory management processes
  • Well developed and practical people management and leadership skills
  •  Excellent verbal and written communication skills
  • Excellent mainstream ERP and general computer skills 
  • Keenly analytical and highly driven, strong personality with high levels of people empathy
  • An exceptional capacity to multi task and work under tight deadlines in a highly dynamic and proactive environment.
  • Exceptional negotiating and people management and directing skills
  • A street smart operator, able to lead, manage , direct and influence those around him with a strong formal technical background and ability to absorb and utilize new sources of information effectively and efficiently.
  • A person looking to achieve and continuously grow rather than just do a 'job'.

 If you believe you are the right person for the above role – we offer a very competitive and negotiable salary for the right person as well as an opportunity to continue to progress in terms of more senior career opportunities.

Please note: The successful candidate will be required to undergo Police, medical, reference and psychometric testing.
 

The application form will include these questions:
  • Which of the following statements best describes your right to work in Australia?
  • How many years' experience do you have in a quality assurance (QA) role?
  • What's your expected annual base salary?

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