In this role you will execute the procedural tasks associated with maintaining and operating the quality system in multiple operational areas within a manufacturing environment. This role works in the vicinity of biological product and hazardous substances.
- Review batch manufacturing records and documentation and release product, chemicals and components.
- Review and process deviations, non-conforming product and corrective actions
- Facilitate quality system documentation (SOP's, Standard Forms, BMRs, etc), including writing, reviewing and issuing documents
- Lead and complete internal audits according to the audit programme to ensure compliance to ISO9001, regulatory requirements and current good manufacturing practices (cGMP).
- Develop product labels
- Train others in quality systems and documentation
- Participates effectively in process improvement teams and completes any assigned actions.
- Completes other activities that support maintaining and operating the Quality System.
- Observe all safety rules which are established to maintain safe work practices, including wearing personal protective equipment (PPE). Conduct proactive hazard identification and report any accidents, incidents and near misses
Qualifications and Experience
- Tertiary Science qualification
- Experience working in a cGMP/ISO 9001 environment in a QA, QC or production role
- Computer literate in word processing, spreadsheets, quality and inventory systems
Skills & Attributes
- Attention to detail
- Disciplined, thorough, methodical, systematic
- Highly self-directed and pro-active
- Excellent communication skills
- Demonstrated ability to articulate and advance cGMP and general quality assurance principles at the shop-floor level.
- Proven team building and team participation skills.
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