Catalent Pharma Solutions Senior Quality Operations Associate in Dee Why, Australia

Job Description

Catalent is seeking a Senior Quality professional to join our dynamic and progressive Quality Team at our Northern Beaches facility.

Catalent Australia is a leading pharmaceutical innovator, formulator, manufacturer and delivery/packaging services specialist. Located in Dee Why, we offer integrated solutions by providing total turn-key solutions for product finishing, pack design, development & product launches to customers in the Pharmaceutical, Consumer Health, Complimentary Medicines, Cosmetic, Clinical and similar industries.

Role Description:

  • To Manage and lead the Quality System and Compliance team providing competent and professional support to the business

  • To provide technical advice on GMP and related issues

  • To provide technical/compliance input to resolution of problems facing the company

  • Lead/drive operational excellence from a quality perspective

  • Be responsible for motivation, training and development of Quality System and Compliance team members to ensure high standard of staff performance

  • Assist the Quality Manager in performance of duties and responsibilities

  • To ensure all documentation processes are performed in compliance with GMP and quality requirements

  • To ensure investigations of customer complaints are thoroughly investigated with appropriate, realistic and meaningful CAPA’s assigned and completed to prevent recurrence

  • To ensure the site is audit ready and that all previous findings have been thoroughly investigated with appropriate, realistic and meaningful CAPA’s assigned and completed to prevent recurrence

  • Oversee the facilities validation program

  • Ensure that all jobs are conducted in accordance with GMP requirements and the Company's Quality Assurance System

  • Ensure all departments are aware of the status of their Controlled Documents and ensure all Controlled Documents relating to the Quality Department are current and compliant.

Experience Requirements:

  • Sound understanding of the Pharmaceutical Industry and current Good Manufacturing Practice (cGMP)

  • Management of people and key stakeholders to achieve outcomes and results

  • Application of core ‘Quality’ based operational streams, e.g, compliance, systems etc.

  • Display initiative and work independently with minimal supervision and as part of a Team

Knowledge/Skill Requirements:

  • Bachelor of Science or related Discipline (preferred)

  • Excellent people skills

  • Ability to lead and develop others

  • Ability and willingness to be a positive influence on others

  • Sound computer skills, e.g, Microsoft suite of Products

  • Excellent problem solving, data analysis, interpretative and reporting skills

  • Demonstrated ability to plan, co-ordinate own workload and meet agreed deadlines

  • Excellent communication skills; listening, written and verbal

  • Must be willing and able to work in a Production environment

This is a great opportunity for a driven and innovative person to join a leading global pharmaceutical service company with a passion for excellence and innovation.

Why Work for Us:

Our Vision is to be the world’s most trusted, reliable and innovative drug development and delivery

partner by upholding the highest industry standards and exceeding customer expectations, while driving

strong, sustained growth for the company.

About Catalent:

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market, for the benefit of patients globally.

Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives.

OUR VALUES are at the foundation of everything we do:

  • Patient First: We put patients at the centre of our work to ensure the safety, reliable supply and optimal performance of our products.

  • Customer Dedication: We strive to exceed our customers’ expectations every day.

  • People: We are committed to the growth, development and engagement of our people.

  • Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes.

  • Integrity: We demonstrate respect, accountability and honesty in every interaction.

  • Excellence: We have a passion for excellence in everything we do.

Catalent. More products. Better treatments. Reliably supplied.™ Visit www.catalent.com/careers to explore career opportunities.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.