Looking for an exceptional candidate who can lead and manager our QA team and take the team to the next level.
- Work in a state of the art facility
- Excellent team culture and environment
- Great coffee and on site parking
Australian Blister Sealing Inc Pty Ltd is looking for an energetic, engaging, well presented, professional with an outgoing personality who will complement our team. Our company was established in 1979 and is now recognised as a leader in pharmaceutical contract packaging. Our state-of-the-art plant is located in Seven Hills in North Western Sydney. This is a senior role which will suit an experienced Pharmaceutical/ Complementary Medicines Quality Assurance Manager to head the Quality Department.
The role is hands-on and relies on your experience and expertise. We provide a quality service packing product in a quality environment and complying with TGA guidelines.
- Manage the staffing and scheduling the duties of the QA department
- Present a professional profile of quality to our client base and to authorities
- Manage and coordinate the approval of supplier’s program
- Oversee and record training of all staff in GMP matters
- Maintain the SOP system and the Quality documentation of the company.
- Liaise with internal and external customer base
- Manage client information for Release for Supply, complementary health knowledge would be beneficial
- Responsible for conducting Release for Supply for both Listed and Registered products
- Perform Product Quality Reviews
- Administer the internal and external audit programs
- Host the TGA and Client routine audits of the facility
- Maintain the CAPA system and investigations
- Handle customer complaints and non-conformances
- Participate in management meetings and reviews
- Provide expert advice and direction in regulatory and quality matters
- Accept overall responsibility for the approval and rejection of starting materials, intermediates and finished products
- Approve batch documentation and samples for release
- Prepare and approve specifications as required
- Maintain GMP agreements with clients and service providers
- Perform risk assessments for the facility and for new product introduction
- Conduct change control investigation and follow up
- Ensure validations are current
- Responsible for obtaining government licenses and permits
- Maintain government licenses and permits
- Responsible for efficient performance of the department.
- Interaction with all levels of the team which gives this rewarding position a vast variety.
For you to be successful you need to be passionate about improving processes, improving productivity and reducing the need for reactive problem solving, you will be expected to manage and utilise your direct team of Quality personnel to determine tasks as well as set and meet agreed KPI's.
Your pre-qualifications & hands on experience in Pharmaceutical Packaging principles will put you in the position to progressively think and challenge your attitude to recommend improvement opportunities to increase quality and efficiency of systems.
All this combined with your excellent literacy, communication, leadership and management skills will ensure long term employment with ongoing advancement opportunities within our growing company.
Necessary Attributes include:
- Qualifications in Science related to pharmaceutical manufacture
- Have previously been responsible as the Quality Licensee and have an understanding of the legal obligations
- Experience in managing a motivated team of quality staff
- History of maintaining or establishing quality systems such as SOP, PQR, Change Control and Deviations
- History of designing, writing and executing validation protocols especially for new equipment (DQ,IQ,OQ,PQ)
- Excellent skills in communication and negotiation
- Strong Leadership skills
You will also have a personal interest in remaining compliant with local and international authorities and modern systems & processes with capacity to further your knowledge that will assist you in presenting innovative solutions and for you to be recognised as a leader in your field.
Most importantly, you are flexible and have the ability to adapt from a large Pharmaceutical Company to a medium sized family owned business. You will have a fair but firm management style with a calm and collected management approach that enables you to work effectively and make the right decisions under pressure, as well as strong time management skills with the ability to multi task and adapt to constantly changing priorities throughout the week. You must have flexibility to meet the demands set by daily changing priorities.
If you believe this is you, we want to hear from you right now. Call us and leave a message with Lina on our answering service and explain how we will benefit by having you as part of our team.
Dial 02 9674 0850 now!
Alternatively, click the link below to apply by email, please include your Resume accompanied with a covering letter explaining how we can benefit by having you lead our quality team
Apply for this job
ABS is a market leader within the pharmaceutical contract packaging industry; we provide packaging services for therapeutic and non-therapeutic goods. Based in Seven Hills, NSW we are an Australian owned and privately-operated company. www.austblister.com