Are you highly experienced in Quality Assurance and thrive on achieving excellence in a dynamic environment? Do you deliver standout results first time, every time? If so, you’ll fit right in at Mayne Pharma.
At Mayne Pharma, the results speak for themselves
Mayne Pharma has a 40-year track record and has set about delivering the highest quality products and strictest quality control protocols for the pharmaceutical industry. This extends to a robust portfolio of branded and generic drugs spanning dermatology, women’s health, men’s health and more.
We’re always searching for ways to improve. That’s why we develop new technologies, delivery systems and products to better serve our customers. To make this possible, Mayne Pharma employs over 450 staff globally.
Culture comes first
We put people first at Mayne Pharma.
And the reason is simple: we know that cultivating a strong culture means we can deliver on our promise ¬– to offer better, safer and more accessible medicines.
To make hard work rewarding, you will enjoy a competitive salary, development opportunities and many health, wealth and lifestyle benefits.
Did we mention our values?
Accountability, agility, creativity, empowerment, integrity and passion. That’s what we stand for. So if these resonate with you, you’ve found the perfect match.
Here’s where you come in
The Quality Assurance Associate (Microbiology Focus) role is one that is both challenging yet rewarding. As a highly experienced professional you will ensure cGMP procedures are followed, supporting the compliance of existing and new Mayne Pharma products and manufacturing processes.
Using your wealth of knowledge, you will mentor and coach other members of the organisation, building their knowledge and confidence in regards to Quality Assurance.
You’ll be supported every step of the way as part of a large, high achieving Quality Team.
Your responsibilities, at a glance, will include:
• Perform and review of Microbiological tasks including but not limited to Bioassay, Preservative Efficacy testing, Microbiological Enumeration of intermediates, Finished Product and Purified Water, Environmental Monitoring, and Media Preparation.
• Microbiological identification of bacteria and fungi, isolated within the pharmaceutical products, manufacturing areas and purified water systems. This includes research into previously unidentified micro-organisms and their effects on products/consumers.
• Validation activities including microbiological assessment of new materials, such as active pharmaceutical ingredients (API) and excipients, as well as identification of microbial contaminants obtained during cleaning validation studies as well as review and evaluation of planned and executed protocols.
• Primary conduit and decision maker between QA and Microbiology in regard to investigations, CAPA’s, change controls and other compliance and reporting requirements.
• Actively make suggestions for development and implementation of new methods/technologies into the Microbiology and QA department. Responsible for developing new and maintaining current microbiological procedures to support cGMP guidelines and investigative technology.
• Performs training of new members of the team or for team members of other departments in specialist areas including Microbiology and Control of Cross-Contamination.
• Maintenance of procedures and processes to ensure compliance with Regulatory and Company quality standards.
• QA release of raw materials, packaging materials, intermediates and finished products.
• Support manufacturing and laboratory investigations using Root Cause Analysis tools.
• Participation in Regulatory, Customer and Internal audits.
• Preparation and analysis of Product Quality Reviews.
• Support New Product Introductions.
• Participate in site Quality Continuous Improvement plans.
You need to tick these boxes
We select applicants based on capability and aptitude. But we also emphasise cultural fit. Therefore, you’ll need to have a positive mindset and be prepared to take ownership of your performance.
To be successful in this role you will also have:
• Tertiary qualifications in a relevant scientific discipline (Pharmaceutical Science, Chemistry, Pharmacy) or related field
• 3+ years of experience in Quality Assurance and/or Microbiology in the Pharmaceutical industry and demonstrated experience in a range of responsibilities and tasks as outlined above as part of this experience (eg: Microbiological identification, Validation processes, Environmental testing, Bioassay, QA Batch Release)
• Computer literate (MS Office Word, Excel and Outlook)
• Thorough knowledge of cGMP
• Ability to work autonomously within a highly functioning team.
• Strong organisational skills with the ability to prioritise and multi task.
• Sound technical knowledge with good communication skills, customer focus and problem solving and decision making skills
• Ability to clearly and logically present complex technical information in written and oral format
• Effective time management and organisation skills, with excellent attention to detail and high level of accuracy
• A flexible, adaptable and responsive approach to changing business needs
Ready to become part of the Mayne Pharma story?
To apply, please forward your application, including a cover letter and resume.
At Mayne Pharma we value work-life balance and support our people in maintaining a strong sense of personal wellbeing and purpose. That’s why we are committed to providing opportunities for our people to grow and develop both personally and professionally and have a strong culture of promoting and developing talent from within.
At Mayne Pharma, the results speak for themselves
Mayne Pharma has a 40-year track record and has set about delivering the highest quality products and strictest quality control protocols for the pharmaceutical industry. This extends to a robust portfolio of branded and generic drugs spanning dermatology, women’s health, men’s health and more.
We’re always searching for ways to improve. That’s why we develop new technologies, delivery systems and products to better serve our customers. To make this possible, Mayne Pharma employs over 450 staff globally.
Culture comes first
We put people first at Mayne Pharma.
And the reason is simple: we know that cultivating a strong culture means we can deliver on our promise ¬– to offer better, safer and more accessible medicines.
To make hard work rewarding, you will enjoy a competitive salary, development opportunities and many health, wealth and lifestyle benefits.
Did we mention our values?
Accountability, agility, creativity, empowerment, integrity and passion. That’s what we stand for. So if these resonate with you, you’ve found the perfect match.
Here’s where you come in
The Quality Assurance Associate (Microbiology Focus) role is one that is both challenging yet rewarding. As a highly experienced professional you will ensure cGMP procedures are followed, supporting the compliance of existing and new Mayne Pharma products and manufacturing processes.
Using your wealth of knowledge, you will mentor and coach other members of the organisation, building their knowledge and confidence in regards to Quality Assurance.
You’ll be supported every step of the way as part of a large, high achieving Quality Team.
Your responsibilities, at a glance, will include:
• Perform and review of Microbiological tasks including but not limited to Bioassay, Preservative Efficacy testing, Microbiological Enumeration of intermediates, Finished Product and Purified Water, Environmental Monitoring, and Media Preparation.
• Microbiological identification of bacteria and fungi, isolated within the pharmaceutical products, manufacturing areas and purified water systems. This includes research into previously unidentified micro-organisms and their effects on products/consumers.
• Validation activities including microbiological assessment of new materials, such as active pharmaceutical ingredients (API) and excipients, as well as identification of microbial contaminants obtained during cleaning validation studies as well as review and evaluation of planned and executed protocols.
• Primary conduit and decision maker between QA and Microbiology in regard to investigations, CAPA’s, change controls and other compliance and reporting requirements.
• Actively make suggestions for development and implementation of new methods/technologies into the Microbiology and QA department. Responsible for developing new and maintaining current microbiological procedures to support cGMP guidelines and investigative technology.
• Performs training of new members of the team or for team members of other departments in specialist areas including Microbiology and Control of Cross-Contamination.
• Maintenance of procedures and processes to ensure compliance with Regulatory and Company quality standards.
• QA release of raw materials, packaging materials, intermediates and finished products.
• Support manufacturing and laboratory investigations using Root Cause Analysis tools.
• Participation in Regulatory, Customer and Internal audits.
• Preparation and analysis of Product Quality Reviews.
• Support New Product Introductions.
• Participate in site Quality Continuous Improvement plans.
You need to tick these boxes
We select applicants based on capability and aptitude. But we also emphasise cultural fit. Therefore, you’ll need to have a positive mindset and be prepared to take ownership of your performance.
To be successful in this role you will also have:
• Tertiary qualifications in a relevant scientific discipline (Pharmaceutical Science, Chemistry, Pharmacy) or related field
• 3+ years of experience in Quality Assurance and/or Microbiology in the Pharmaceutical industry and demonstrated experience in a range of responsibilities and tasks as outlined above as part of this experience (eg: Microbiological identification, Validation processes, Environmental testing, Bioassay, QA Batch Release)
• Computer literate (MS Office Word, Excel and Outlook)
• Thorough knowledge of cGMP
• Ability to work autonomously within a highly functioning team.
• Strong organisational skills with the ability to prioritise and multi task.
• Sound technical knowledge with good communication skills, customer focus and problem solving and decision making skills
• Ability to clearly and logically present complex technical information in written and oral format
• Effective time management and organisation skills, with excellent attention to detail and high level of accuracy
• A flexible, adaptable and responsive approach to changing business needs
Ready to become part of the Mayne Pharma story?
To apply, please forward your application, including a cover letter and resume.
At Mayne Pharma we value work-life balance and support our people in maintaining a strong sense of personal wellbeing and purpose. That’s why we are committed to providing opportunities for our people to grow and develop both personally and professionally and have a strong culture of promoting and developing talent from within.
