Category

Description

• Drive the design and equipment procurement in the establishment of a new analytical laboratory
• Establishment of test methods by technology transfer from head office and in house development
• Establish and manage external contract testing capabilities
• Manage the qualification of all equipment and the validation of test methods.
• Prepare new Quality Documents and revision/update of existing documents within the ownership of the QC group.
• Hire, train and mentor QC and analytical staff
• Manage rostering to ensure continuity of service up to two shifts and 7 days
• Run and participate in risk assessments, internal audits and quality investigations relevant to area of responsibility or expertise.
• Manage the sampling and testing of intermediates or products.
• Manage the sampling and testing of chemicals and raw materials for release, including pharmaceutical water testing
• Manage calibration and maintenance activities for all quality control equipment in line with documented schedules
• Maintain quality control testing records and data entry ensuring industry standard data integrity principles are maintained.
• Establish and maintain a stability testing program for products and intermediates in compliance with ICH guidelines.
• Preparation of specifications for testing of materials and products
• Overall responsibility for the environmental monitoring program

• At least 5 years experience in a similar laboratory management role, with experience managing multidisciplinary teams
• Tertiary qualifications in a science discipline (Microbiology/Bio Science) or equivalent accumulated experience.
• Hands on experience with one or more of the following analytical techniques: HLPC, GC
• At least 10 years’ experience in a GMP pharmaceutical manufacturing or analytical environment would be an advantage
• Demonstrable experience in method validation is required
• Demonstrable experience presenting and defending the quality control department during regulatory inspections (ie TGA) or to external customers.
• Advanced knowledge of TGA PIC/s or related international requirements

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