Senior Product Quality Officer 2:30pm

5 days ago

Auckland, New Zealand Jaychem Industries Full time

Senior Product Quality Officer 2:30pm - 10pm Senior Product Quality Officer 2:30pm - 10pm Quality Assurance & Control (Manufacturing, Transport & Logistics) Master’s degree in Life Sciences & 3 years of c GMP experience in Production.
Or Bachelor’s degree in Life Science & 5 years of c GMP experience in Production.
EXPERIENCE: Excellent knowledge of and experience with GMP processes involved in production including working knowledge of contamination control, deviation investigation and batch decision on product quality, line clearance, batch production record review, product quality review improvements and regulatory requirements.
Experience as Authorised Person in release and reject of batches an asset.
Experience in participating in regulatory audits (i.e.
MPI ACVM, FDA, MEDSAFE, TGA) Excellent experience in process and cleaning validation protocol generation, and facility and utility qualification protocol generation.
Strong computer operation skills including word processing, 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 material, production and labelling and packaging systems.
Extensive knowledge and application of GMP facility and equipment, material, production and labelling and packaging 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. Confident ability to interact with regulatory agencies both orally and in writing. 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, leading teams and to effectively interact with various levels.
Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities and follow assignments through to completion.
Must be able to handle multiple projects concurrently. SPECIFIC DUTIESEnsure all Material and Production Batch Disposition (Release/Reject) is performed according to relevant Standard Operating Procedures (SOP’s), Work Instructions (WIs) are accurate and within their review dates as well as initiating changes to Procedures and Master Batch Production Records.
Perform the following Quality principal duties: Ensure good housekeeping and 5 S methodology is applied to the workspace.
Ensure Environmental and Contamination control for the production areas and water is maintained and monitored to ensure product quality assurance which includes sample collection, dispatch to testing laboratory, review of results to specifications and trend reports.
Ensure product / process quality, perform activities to facilitate the release of product to the marketplace, and ensure proper control of material. Provide Quality support directly to the production floor, to include oversight for adherence to c GMPs, right-first-time completion of production GMP documentation, and effective investigation of atypical events.
Additionally, spend significant time on the shop floor to partner with Operations to enable right first-time production, to learn the manufacturing process, and to ensure compliance with c GMPs and regulatory requirements. Generation and lead complex investigation reports to approval with decision on disposition of impacted batches.
Generation of process and cleaning validation protocols as well generation of facility qualification protocol and utility qualification e.g water system in associated with changes.
Communicate with Suppliers with respect to inwards raw materials and documentation requirements.
Dispatch of samples for their respective testing requirements.
Perform document / logbook audits for accuracy and completeness.
The individual will also work closely within a team environment to ensure timely review documentation and that is done right first time.
Perform 100% audit of process documents / logbooks to ensure completeness and accuracy for assigned functional area.
Provide coaching and mentoring of Operations personnel with regards to documentation completion.
Coordinate with Operations to discuss, resolve, and eliminate documentation observations.
Perform GMP walk through inspections of assigned departments within organization to ensure compliance with c GMPs and regulatory requirements.
Ensure proper identification of release status and control of materials through maintenance of quarantines in the ERP system and through physical tagging of material as required.
Perform Quality review / approval of new and updated SOPs & WIs.
Assist with training of incoming personnel and ensure compliance with departmental procedures.
Actively participate in the departmental communication process and use this forum to escalate concerns and best practices.
Collaborate with members from other support groups within the functional organization, in the identification and implementation of continuous improvement initiatives and action plans.
Work with necessary groups within the functional area to resolve outstanding issues with process documents / logbooks, GMP walk through inspection observations, and quarantine management.
Perform deviation management, environmental monitoring investigations, and inspection support.
Complete training and is qualified to review qualification documents, change requests, and atypical event investigations.
Prioritize review of process documents / logbooks in order to maximize cycle-time efficiency.
Perform ERP transactions for material disposition.
Support production shift changes, inspection support, risk assessments, and providing quality input as applicable or escalating as necessary.aychem Industries TGA, APVMA, MEDSAFE, ACVM: My Company | Linked In Your application will include the following questions: Which of the following statements best describes your right to work in New Zealand? Report this job advert Don’t provide your bank or credit card details when applying for jobs.

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