Document Controller Quality Compliance Officer Flexible Hours

Document Controller Quality Compliance Officer Flexible Hours

Jaychem Industries Ltd

Document Controller Quality Compliance Officer Flexible Hours

Details of the offer

PERSONAL SPECIFICATIONS QUALIFICATIONS Minimum NCEA IB level 1 or Bachelor degree in Life Science or combination 1 3 years of cGMP experience in Quality Systems EXPERIENCE Good knowledge of and experience with GMP processes involved in quality systems including working knowledge of document records control change controls design approval and issuance of batch records PACA Deviations Complaints Supplier Qualification Audits Inspections Recall product quality review improvements and regulatory requirements Experience in participation in audits and participating in regulatory audits i e MPI ACVM FDA MEDSAFE TGA Strong computer operation skills including word processing adobe visio presentation database and spreadsheet application skills Excellent technical writing and communication skills in English Maori an asset facilitation and presentation skills SKILLS AND APTITUDE Proficiency with some quality systems Some knowledge and application of GMP Quality Systems regulations and standards e g PIC S MPI MEDSAFE TGA FDA pertaining to the production of pharmaceutical veterinary products and ability to evaluate compliance issues Advanced route cause data analysis and skills in solving complex problems Elevates issues to management when appropriate Strong team player able to focus on departmental goals whilst respecting the needs of others as well as working independently and effectively interacting with various levels Skill in handling multiple responsibilities tasks and projects simultaneously including ability to shift priorities and follow assignments through to completion POSITION DETAILS REPORTS TO Quality Compliance Manager DEPARTMENT Technical Quality Assurance PURPOSE The primary responsibility for this position will be supporting and managing the Quality Systems and GMP compliance activities with a focus on continual improvement DIRECTLY SUPERVISING NA DEPUTY NA WORKING RELATIONSHIPS All staff SPECIFIC DUTIES Ensure all Quality Systems is performed according to relevant Standard Operating Procedures SOP s Work Instructions WIs which are accurate and within their review dates as well as initiating changes to Procedures Following Quality principal duties Ensure good housekeeping and 5S methodology is applied to the Office Work closely with functional managers to support implementations of processes for activities that ensure the site manages and mitigates risk and maintains compliance Identify areas for continual improvement of the Quality Systems Support administration of internal and external Quality systems including change control training deviation PACA and product complaints Assist with updating and maintaining Quality Department operations logs and databases Manage GMP documents by writing reviewing and or workflows Assess and approve quality system documentation including implementing and coordinating all activities relating to the control distribution maintenance and archiving of GMP Quality documentation Coordinate change control processes for SOPs master batch packing records specifications test methods validation protocols reports technical protocols reports and other GMP documents Ensure management of changes associated with products and processes are carried out appropriately using science and riskbased assessment to determine the impact of change Maintain training files Attend and actively participate in relevant training sessions Track and assess supplierinitiated changes and vendor complaints Manage change control associated with supplier changes including data collection forms for supplier related changes for new and changed part numbers Coordinate activities and supporting interactions during regulatory agency inspections and customer audits Support the site Inspection Readiness initiatives Support annual internal audit schedule with consultation from the Quality team and relevant internal stakeholders to identify areas of focus Support supplier assessments through questionnaires or onsite audits Understand service level and quality agreements that demonstrate achieving specific quality standards Ensure that audit results are formally recorded and reported and that corrective preventive actions are documented Provide suitable recommendations for internal audit observations ensure auditees deliver appropriate PACAs and follow them through to closure Escalate as appropriate where resolution of internal audit findings is inadequate Mentor personnel in the organization as requested by the Head of Quality Perform other Quality duties as assigned and other GMP activities as needed Support Data Integrity reviews at the site Perform gap analysis of Quality Systems to new and existing regulations and standards Provide metrics and Key Performance Indicators KPIs for management of risks and compliance

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