Quality Assurance & Quality Control (QA & QC) Manager |
Quality Assurance & Quality Control (QA & QC) Manager
We are looking for “QA & QC Manager” with the following job description and requirements:
Duties & Responsibilities
Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and clients’ standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
Develop and maintain a Quality Management System in accordance with domestic and international medical device regulatory requirements (FDA, ISO13485, MDD, Health Canada, etc.)
Manage Quality Control related activities regarding all in-process checks, deviations, RM release, and finished product release. Ensure that products conform to specifications and regulatory requirements.
Approve or reject all formulations, procedures, specifications, test methods, raw materials, packaging materials, and finished products, including products manufactured at foreign sites, based on conformance / non-conformance to respective specifications that affect the purity, quality, and composition of each product.
Oversee complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration, and control of nonconforming material.
Maintain and improve product quality by completing product and company system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop a new product, and manufacturing and training methods.
Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
Approve Raw Material Specifications before purchase. Develop Finished Product Specifications for existing & New Products.
Prepare a Certificate of Analysis for all clients, prepare Stability reports and Nutritional Facts for products.
Maintain Master formulations, Change Control, and history records. Develop & make a master formula for all new registrations. Identify and analyze issues related to in-process manufacturing and resolve them.
Review & maintain Work Orders and all related documents. Complaint handling: record all details about the complaint and prepare a complete investigation report, corresponding to the client till it’s resolved.
Communicating with clients and Laboratory for technical matters. Ensure that the contract laboratories are capable of performing all of the tasks and responsibilities assigned to them.
Review and verify test protocols, COA’s received from the third-party laboratory. Investigate OOS results received from the laboratory and find solutions.
Minimum BSc. in Chemistry, Biology, Pharmacology, or Food Science obtained by recognized University.
Around 5 years of experience in a Natural Health Supplements/pharmaceuticals manufacturing environment.
Basic knowledge in CFIA FSEP Manual and HACCP System preferred.
In-depth understanding of quality systems such as ISO 9000, GMP, FSSC 22000, HACCP training certification.
Knowledge in Natural Health product formulation is an asset.
Flexible and able to operate in a fast-paced environment.
Excellent numerical skills and understanding of data analysis/statistical methods.
Good knowledge of MS Office and databases.
Great attention to detail and a result-driven approach.
Excellent organizational and leadership abilities.
Salary: Based on experience. Job Location: Maple Ridge, BC Job type: Full time permanent Benefits: After the probationary period