Do you have extensive experience in pharmaceuticals, laboratories, biology, and/or medical devices?
Are you passionate about Quality and GMP Best Practices?
Are you passionate about using your experience and skills to develop the next generation of Quality/GMP professionals in our sector?
Are you based in Sydney?
If the answer is yes to all of these, then this job is for you.
SeerPharma's mission is to advance Quality and GMP Best Practices to Pharmaceutical and Medical Device companies in the Asia-Pacific region. We look to achieve this by offering advisory, training and software solutions to help companies address the Quality and GMP compliance issues they may face.
SeerPharma has pursued our mission for over 35 years. We have an outstanding history of successful work with a broad client base across the APAC region and a great team of over 30 providing assistance with a vast cross-section of the major international standards, including PIC/S, FDA, EU, WHO and ISO.
We have a friendly and inclusive culture, and testimony to this is the length of time our staff stay at SeerPharma.
We have a strategic partnership with the University of Technology Sydney (UTS), where our team delivers our Postgraduate GMP program. A Full-time position has arisen for a self-motivated GMP Trainer/Consultant to join the SeerPharma team in Sydney.
The GMP Trainer/Consultant will assume responsibility for executing GMP training to Postgraduate University students at UTS, and deliver training as requested by industry. In addition, the role will involve providing advisory support to the industry on matters related to Quality/GMP, where scheduling permits.
Working Relationships
Extensive contact with SeerPharma management and other trainers across our business. The incumbent will report directly to the Training Manager with a dotted line to the Consulting Manager. The GMP Trainer/Consultant is anticipated to collaborate with consultants and sub-contractors from Melbourne, Sydney and Singapore and with university staff and students.
Key Result Areas (Areas of Responsibility)
Post-graduate University GMP training and competency assessment
* Strong teaching and mentoring skills.
* Creating materials to assist the students in class workshops and preparation.
* Updating the materials used for teaching on the teaching platform.
* Ability to implement course or curriculum development.
* Excellent presentation, written and verbal communication.
* Proficiency with new learning technologies.
* Experience in current learning platforms.
* Experience with the development of the course.
* Ability to manage teaching multiple courses and deadlines for both on-campus and online students.
* Willingness to maintain regular on-campus presence.
* The ability to work autonomously.
* Liaising with university staff regarding students and course feedback.
* Marking assessments to meet the release deadlines to students.
* Timely feedback to the students and prompt response to student emails.
* Promotion of the Masters of Good Manufacturing Practice course.
* Willingness to work strongly with the team and provide on-going support when required.
* Potential requirement to work outside of regular working hours.
* Setting and correcting assignments, exams and portfolios
* Updating subjects to ensure any changes in regulatory guidelines are captured, and
Industry
* Public/On-Site Training to Industry
* Support the SeerPharma consulting business.
* Be actively contributing to training program development with the SeerPharma Training management team.
* The consulting and industry training will be in the following areas:
* GMP, GLP and CSV compliance consulting to TGA, EU and FDA requirements
* Quality Management Systems documentation preparation
* Gap analysis and auditing
* GMP, GLP, Validation (including CSV) training at enterprise and public levels
* Validation documentation preparation and support client validation projects
* Establish and extend business and client relationships within Australia
* Actively market SeerPharma services and products within Australia
* Prepare proposals and contracts in consultation with the SeerPharma Management team
* Co-ordinate individual contracting projects (deal with contractors and clients)
Qualifications and Competencies Required (competencies, skills, education)
The successful candidate must have the following profile and attributes:
Competencies
* A tertiary qualification in chemistry, microbiology, biochemistry, engineering or equivalent related discipline
* Able to present effectively to students, drawing from own experience and using real examples
* At least 5 years, and ideally up to 8 years experience in the pharmaceutical, biotechnology or equivalent industry in quality assurance, GMP/GLP compliance, operations or validation
* Able to prepare professional standard client reports and other documents
* Exposure to, and knowledge of, international cGMPs and Quality Assurance (TGA, FDA and/or EU)
* Able to work within a small project team
* Proactive and customer focussed
* Exposure to implementation of quality assurance/GMP/GLP programs
* GMP, GLP and/or validation training experience
* GMP, GLP auditing experience to TGA, FDA or EU standards
Marketing and Relationship Skills
* Ability to market SeerPharma services and products to multinational clients and senior managers such and General Managers, QA Directors, Validation Managers, and Training Managers
* Ability to prepare and present sound proposals to clients
* Skills in developing and maintaining client and business relationships
* The successful candidate will be expected to travel interstate and overseas from time to time
Self-Direction and Autonomy
· Negotiates and prioritises work assignments
· Work independently and takes initiative
· Motivational team leader and member
· Motivated and professional approach to business development
· Ability to solve problems autonomously
This role is for Australian Citizens/Permanent Residents only