Your responsibilities will include:
- Coordinate and direct the functions and staff of the Quality Operations Unit (Raw Material and Batch Release, Stability and Investigations), to ensure efficient, effective and compliant systems are in place in order to provide sound service to internal /external customers.
- Act as the responsible person for the PGS Melbourne Operation for the subsequent disposition of finished product and raw materials.
- Manage the stability program to ensure batches are appropriately selected and placed on stability to ensure regulatory compliance of the stability program.
- Carries out performance appraisals according to QA procedures ensuring annual and half yearly performance appraisals are conducted on time.
- Provides leadership and pro-active management and direction - Coaching local leadership on behaviors required to drive cultural change.
- Work with all levels of organisation to develop and drive continuous improvement plans.
- Establish meaningful Quality Operations Performance metrics, together with systems for monitoring results and identifying success and defaults in a timely manner for appropriate action.
- Establish and maintain safety management for Quality Operations staff in accordance with Legal requirements and Site and Company Policy.
- Provide review, approval and support, as required, according to relevant procedures
- Batch Release
- Vendor Qualifications
- Regulatory Support
- Internal Audits
- External Inspection/Audit Hosting and support
- Site Quality Management Review
- Annual Product Quality Reviews (APQRs)
Instill Quality Culture encompassing continuous improvement and development / implementation of best practices in Quality Operations Unit.
To be considered for this opportunity you will have:
- Minimum Bachelor's Degree in an Engineering, Scientific or related discipline.
- At least 5-10 years' experience leadership within Quality (QC/QA), with 10 years experience in the Pharmaceutical Industry.
- Demonstrates knowledge of cGMP and Regulatory requirements for Australia, EMEA and USA.
- Demonstrated leadership and communication skills.
- Demonstrated success in leading, coaching and developing colleagues.
- Successful track record of continuous improvement and development / implementation of best practices in Quality Operations or manufacturing.
- Thorough knowledge and understanding of the technical regulatory and commercial aspects of pharmaceutical products is required.
- Possess excellent verbal, written, presentation and interpersonal communication skills.
- Detailed knowledge of Good Manufacturing Practice.