SAMUEL CHRISTIAN
Summary
Detail-oriented and highly organized Quality Associate with extensive experience in TGA and GMP environments across diverse company settings in Australia and New Zealand, specializing in the complementary medicine and food manufacturing industries. Demonstrated commitment to ensuring compliance with stringent quality standards while implementing effective quality control measures that enhance operational efficiency. Eager to leverage expertise in a challenging role within a reputable organization, contributing to success and upholding a commitment to excellence. A proactive approach to problem-solving and continuous improvement drives a passion for maintaining the highest quality benchmarks.
Overview
22
22
years of professional experience
Work History
Quality Assurance Associate – Authorized Person
LIFE-SPACE GROUP
08.2024 - Current
- Perform review and approval of the batch manufacturing and packaging records to ensure quality standards and specification are met throughout manufacturing and packaging process.
- Perform Release for Supply and Release for Distribution of products manufactured on site or at OEM as an Authorized Person ensuring batch is produced meeting specification and marketing authorization.
- Responsible for ensuring that all deviations, OoS, change controls and any other associated document with batch release is closed before Release for Supply process.
- Ensure a review of product stability data is conducted as part of Release for Supply process.
- Assist with batch documentation process which include prepare, review and approve batch records and material lists for Primary and Secondary packaging.
- Collate, review and trend test results for GMP materials, bulk and finished products.
- Responsible for Approval or rejection of starting materials, packaging, intermediates and finished products.
- Assist with preparation and review of Deviations, CAPAs, Change Controls and Out of Specification.
- Assist with timely implementation of change related actions and documentation effectivity in accordance with market approvals.
- Responsible for approval of new product manufacturing trial documents as part of NPD projects.
- Prepare, review and approve Certificate of Analysis and Trend Record for Finish product batches.
- Prepare, review and approve Finished Product Specifications.
- Assist with the management of stability program which include preparation, review and approval of stability protocols and reports.
- Preparation and review of company SOPs, other controlled procedures and documents.
- Assist with new staff member training when required.
- Participate in inspections that are performed by TGA or other regulatory agencies in area of responsibility.
- Performing routine walkthroughs of manufacturing and packaging suites to ensure GMP compliance and best practices are always followed.
- Participate in cross-functional team activities such as investigations, risk assessments.
- Ongoing review of processes and the potential for improvement.
Quality Assurance Associate
LIFE-SPACE GROUP
09.2020 - 07.2024
- Perform review and approval of the batch manufacturing and packing records to ensure quality standards and specifications are met throughout the production run.
- Preparation and review of Specifications and other associated documents related to sampling, testing and method validation for bulk and finished products.
- Assist with preparation and review of batch manufacturing and packaging records.
- Preparation of Risk Assessment and collating data for raw material shelf-life extension.
- Prepare and review raw material, primary packaging material master specifications.
- Responsible for Approval or rejection of starting materials, packaging, intermediates and finished products when required.
- Prepare change controls, deviations, OoS and CAPAs.
- Prepare and review and approve secondary printed packaging (sleeve, label, unit carton, shipper) master specification ensuring approved artwork proof matches printed packaging received.
- Prepare Certificate of Analysis and Trend Record for all Finished Product.
- Maintain an electronic filing system of all Quality documents.
- Assist with preparation of stability protocol and reports.
- Prepare and participate in regulatory and internal audits.
Quality Assurance Officer
GOOD HEALTH PRODUCTS
04.2017 - 05.2019
- Review and approve batch manufacturing and packing documentation to ensure quality standards, specification and approved processes are met throughout the production job.
- Release finish products for sale ensuring quality standards have been met and product is suitable for distribution and use.
- Conduct daily in-process quality checks along manufacturing and packing lines to ensure that quality standards are being attained.
- Conducting Internal audits and providing support during external audits when requested.
- Management (investigation, response) of customer complaints of Finish Products.
- Reporting and conducting monthly environmental swab sampling of different production rooms, machine parts to support Risk Management Program (RMP).
- Preparation and review of SOPs, product specifications, forms and quality documentation.
- Prepare secondary printed packaging (label, carton, foil) master specification ensuring final artwork proof matches printed packaging received.
- Assist in monitoring production processes and practices to ensure all standards and safety measures are being always met.
- Assist with Deviation, CAPA and Change Control processes.
- Assist with production staff training as required and requested.
- Management (rework/RTV/dump) of non-conformance goods.
- Building strong relationship with cross functional stakeholders like Quality Control, Production, Product Development, Marketing, Supply Chain and Warehouse to implement strong quality culture mindset.
- Prepare Certificate of Analysis for export customers.
Quality Control Officer
GOOD HEALTH PRODUCTS
04.2006 - 04.2017
- Conduct aseptic sampling of all incoming goods (raw material, bulk, primary and secondary packaging material and contract finish product) to appropriate procedures.
- Coordinate material and product samples for testing with internal and external laboratories to test requirements as per the procedures.
- Organizing product samples to be sent to external laboratories for testing if necessary.
- Conduct sampling and inspection testing of primary and secondary packaging materials.
- Coordinate with Procurement/Supply Chain to ensure incoming materials have correct and required documents.
- Organizing and assisting with external inspections of an imported Biosecurity and Animal derived materials by Ministry for Primary Industries.
- Management (sample, record and storage) of retention samples.
- Perform laboratory testing as required to appropriate procedures.
- Release or reject GMP materials (raw, packaging) and products (bulk, contract finish) to indicate quality status (QC passed/Reject) as per documented procedures.
- Assist in writing and improving QC procedures, forms and specifications against appropriate Pharmacopoeia.
Production Operator (Part-time)
GOOD HEALTH PRODUCTS
05.2004 - 04.2006
- Maintain and complete GMP batch documentation.
- Conduct aseptic dispensing (accurately weighing and measuring) and blending (mixing) of raw materials as per documented procedures.
- Perform visual QC checks of products along production lines.
- Follow SOPs that apply in all relevant areas.
- Ensuring equipment are running smoothly.
- Liaise with multiple departments (engineering, quality control, quality assurance etc.).
- Troubleshooting machinery along lines.
- Work well independently and with others within a team environment.
- Ensure the production areas and equipment are clean.
Education
Bachelor of Science - Chemistry
Gujarat University
IndiaHigher secondary school certificate - undefined
Gujarat Secondary Board Examination
Internal Auditing - undefined
New Zealand Quality College
AucklandSkills
- Great attention to detail and high degree of accuracy
- Confident in prioritizing and maintaining efficient time management skills
- Ability to interact and communicate effectively by gaining trust and maintaining a professional relationship
- High ethical standards, self-motivated, result oriented, respectful, and compassionate
- Confident in decision making skills by utilizing assessment skills and critical thinking
- Ability to work well under pressure to meet business requirements
- Strong interpersonal skills and ability to interact with cross section of departments
- IT skills including experience in Microsoft Office (Word, Excel, Outlook)
- Maintain professional boundaries, accountability, and confidentiality
- Experience and commitment in working as part of a team as well as individually under little supervision
Timeline
Quality Assurance Associate – Authorized Person
LIFE-SPACE GROUP
08.2024 - Current
Quality Assurance Associate
LIFE-SPACE GROUP
09.2020 - 07.2024
Quality Assurance Officer
GOOD HEALTH PRODUCTS
04.2017 - 05.2019
Quality Control Officer
GOOD HEALTH PRODUCTS
04.2006 - 04.2017
Production Operator (Part-time)
GOOD HEALTH PRODUCTS
05.2004 - 04.2006
Higher secondary school certificate - undefined
Gujarat Secondary Board Examination
Internal Auditing - undefined
New Zealand Quality College
Bachelor of Science - Chemistry
Gujarat University