QA Validation Associate – Pharmaceutical Manufacturing

QA Validation Associate – Pharmaceutical Manufacturing (The position has been filled)

• Excellent opportunity for a Professional experienced in Validation within the Pharmaceutical Industry
• New innovative products, state of the art facilities and friendly work environment
• Attractive salary and guaranteed career progression for the right person

 

CLIENT

Our client is a high profile, Australian owned business, which manufactures dermatological skin care under a TGA licence. Established more than sixty years ago, their brands are utilised by people around the globe on a daily basis. The company is trusted for the high quality of its products and its innovation which  has led to extraordinary growth.

To employees, our client offers excellent facilities, career progression, and a supportive, friendly and professional work environment.

 

THE ROLE

If you are looking for an opportunity to be involved in the manufacture of innovative products and to be part of an experienced QA team, apply now!

Due to growth, our client requires a motivated professional with at least five years’ industry experience in a similar role in pharmaceutical manufacturing. The ideal candidate will have a tertiary qualification in science, or a related discipline plus an in-depth knowledge of validation and understanding of relevant regulatory and compliance requirements applicable in a GMP facility.

Key Responsibilities:

• Preparation of validation activities associated with changing existing processes, implementing new processes and during development of novel products
• Preparation of process validation protocols for manufacturing method changes
• Authoring validation protocols and reviewing of various compliance documentation
• Qualifying manufacturing equipment and critical utility systems used in the manufacturing facility
• Working with stakeholders such as Production and R&D Departments to ensure process validation scheduling and completion of validation documents
• Reporting of results and any issues that may arise to Quality Systems Manager
• Preparation of Regulatory Process Validation Reports
• Participating in inspections that are performed by the TGA or other regulatory agencies
• Implementing corporate policies through providing of procedures and supporting the practices necessary to maintain compliance with them

 

SELECTION CRITERIA

The successful candidate will be a professional with at least five years’ experience in pharmaceuticals and able to demonstrate a history of participation in inspections performed by TGA and other regulatory agencies. To be shortlisted for consideration for this permanent role, you will have worked in similar positions and will have a detailed knowledge of product process and cleaning validation  in the pharmaceutical industry.

To be successful in your application you must meet the following criteria:

• Possess a relevant tertiary qualification in Science such as Chemistry or Microbiology
• Have minimum of five years’ experience in similar role(s), specifically within the area of process and cleaning validation in the pharmaceutical industry
• Be knowledgeable of the regulatory guidelines applicable to the validation of equipment and its cleaning and manufacturing processes
• Communicate through well-developed interpersonal skills, which engender teamwork and embody leadership qualities
• Be familiar with GMP and its application in the pharmaceutical industry
• Have the capability to critically evaluate documentation within a Validation Master Plan and writing skills necessary for revising components and drafting new content
• Demonstrate the competency to monitor environmental conditions and conduct audits of areas of responsibility
• Initiative and proactive approach – you must be able to work under minimal supervision
• High attention to detail and strong writing skills will see you shortlisted

 

APPLICATIONS

To apply for this role, click the ‘Apply Now’ button to send your updated resume and a covering letter addressing selection criteria to CS Executive Group.

Alternatively, for a confidential discussion about this role, please call us on +61 3 9516 0100 during our office hours.

 

THANK YOU

We would like to thank you for taking the time to apply for this role. Unfortunately, due to the large volume of candidates we receive daily, we can only contact those with suitable qualifications and experience. Accordingly, if on this occasion you are not successful in being shortlisted, your resume will remain on our database and be considered for future suitable roles.