Validation Support Officer

Quality Balcatta, WA


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

Based in Balcatta, this role will be responsible for assisting in the preparation of user requirements, equipment specifications and the design / execution of validation experiments associated with the equipment and processes used for the manufacture of pharmaceutical products. This includes utilities such as compressed air, HVAC and water purification and manufacturing equipment such as bulk blending equipment, bottle/tube filling lines and secondary packing equipment. You will need to be able to work in a team environment with good people skills, be self-motivated and use initiative. Attention to detail and computer literacy essential.

Duties:

  • Coordination of the site's annual validation plan
  • Prepare or review User Requirements and Design Specifications to ensure equipment is safe, capable of meeting process requirements and is fit for purpose.
  • Preparation and execution of validation protocols for equipment and processes using a science and risk based approach.
  • Preparation and execution of validation protocols for cleaning validation using toxicological limits.
  • Write reports to document the outcome of validation trials / experiments and production test batches.
  • Key member of project teams for new utilities, equipment, computer systems and processes.
  • Initiate new and update existing work procedures (standard operating procedures).
  • Providing technical support to Production and Quality Assurance departments.


Skills & Experience:

  • Bachelor's degree in Science, related discipline or equivalent.
  • A minimum of 5 years' validation experience within the pharmaceutical industry.
  • An understanding on the strategies for managing the risk of cross-contamination according to the ISPE Guideline Risk-MaPP.
  • Well-developed interpersonal, organisation and communication skills, the ability to work effectively with staff members at all levels, strong technical writing skills and familiarity with cGMP and TGA regulations.
  • Computer proficiency with a working knowledge of Microsoft Office (Excel and Word).
  • An understanding of equipment and processes associated with manufacture of liquid, cream, gel, ointment and suppository products.
  • A demonstrated ability to work independently on multiple concurrent projects with minimal guidance and to meet project deadlines.
  • Knowledge of lean manufacturing systems, six sigma and statistical process control techniques is an advantage.  

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.