Quality Assurance Specialist

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.

Reporting to the Quality Assurance Technical Manager this position is responsible for the management of the finished product batch review and release process, the Process Deviation & Investigation, Quality Event Systems and Customer Complaint System. This position will liaise with key production, warehouse and customer service department personnel and includes the supervision of Compliance and Quality Systems department staff.

Duties

  • Ensure product is manufactured, stored and distributed in accordance with Perrigo’s policies and procedures, and relevant regulatory requirements.
  • Review deviations in accordance with company procedures and ensure suitable assessment of impact on quality, safety and efficacy has been performed and documented; Ensuring efficient and effective corrective and preventative action is implemented to prevent the reoccurrence of quality issues.
  • Determine appropriate finished product batch disposition in accordance with Perrigo Australia procedures and regulatory requirements
  • Co-ordinate, maintain and improve Process Deviation system, Quality Event system and Customer Complaint system.
  • As required conduct investigations into process deviations, quality events as well as customer complaints and implement required corrective and preventative actions
  • Ensures that internal audits are conducted in accordance with current procedure and coordinates and administers the internal audit programs.
  • Review and approval of controlled documents including but not limited to SOP’s, batch documents, periodic product quality reviews and controlled forms.

Skills & Experience

  • Tertiary qualifications in Science, Pharmacy or Engineering
  • Experience in the development, operation and assessment of relevant quality control, assurance and management systems.
  • A minimum 5 – 7 years’ experience in the pharmaceutical industry
  • Demonstrate involvement in TGA inspection (Inspection standards: PIC/S Guide to Good Manufacturing Practice for Medicinal Products and/ ISO 13485)
  • Specific understanding of the requirements of Release for supply of medicines
  • Exceptional skills in organisation, planning and communication
  • Proficient in Microsoft Outlook, Excel, Word, Power point and ability to learn new software applications
  • Supervisory experience.
  • Must have full Australian working rights.
If your are interested in this opportunity please submit your resume with a covering letter that best demonstrates your ability to meet the above requirements no later than COB 11th December 

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.