31 Aug
|
Dr. Attlee
|
Calgary
31 Aug
Dr. Attlee
Calgary
职位简介Position Summary
中文:
我们是一家专注于加拿大市场天然健康产品(Natural Health Products, NHP)的公司,现招聘一名专业的质量保证负责人(Quality Assurance Person / QAP),负责建立、维护和监督公司的质量管理体系,确保产品及相关质量活动符合加拿大 Health Canada NHP Regulations 和 GMP 要求。
English:
We are a company specializing in Natural Health Products (NHPs) for the Canadian market. We are seeking a qualified Quality Assurance Person (QAP) to establish, maintain, and oversee our quality management system and to ensure that our products and quality-related activities comply with applicable Health Canada NHP Regulations and GMP requirements.
主要职责Key Responsibilities
1. 中文:
负责公司 NHP 质量保证体系的建立、实施、维护和持续改进。
English:
Establish, implement, maintain, and continuously improve the company's NHP quality assurance system.
2. 中文:
确保产品、原料、包装材料及相关质量活动符合加拿大 NHP GMP 要求。
English:
Ensure that products, raw materials, packaging materials, and related quality activities comply with Canadian NHP GMP requirements.
3. 中文:
审核和批准供应商、原料、成品及相关质量文件。
English:
Review and approve suppliers, raw materials, finished products, and relevant quality documentation.
4. 中文:
审核 COA(Certificate of Analysis)、产品规格、批生产记录及检测报告。
English:
Review Certificates of Analysis (COAs), product specifications, batch records, and laboratory test reports.
5. 中文:
负责产品上市前的质量审核及 Batch/Lot Release。
English:
Conduct pre-market quality review and authorize the release of finished product batches/lots prior to sale.
6. 中文:
建立、审核和维护 SOP、产品规格、质量记录及其他质量体系文件。
English:
Establish, review, and maintain SOPs, product specifications, quality records, and other quality-system documentation.
7. 中文:
负责 Deviation、OOS、CAPA、Change Control 等质量事件和质量体系管理。
English:
Manage quality events and systems, including Deviations, Out-of-Specification (OOS) results, CAPA, and Change Control.
8. 中文:
负责客户投诉、产品质量调查及必要时的产品召回程序。
English:
Manage customer complaints, product quality investigations, and product recall procedures when required.
9. 中文:
参与原料及供应商资格审核和供应商质量管理。
English:
Participate in raw material and supplier qualification and supplier quality management.
10. 中文:
负责内部 GMP 审计,并协助公司应对 Health Canada GMP 检查。
English:
Conduct internal GMP audits and support the company during Health Canada GMP inspections.
11. 中文:
确保质量相关培训得到实施,并建立完整的培训记录。
English:
Ensure that quality-related training is implemented and that complete training records are maintained.
12. 中文:
根据公司业务和产品发展持续完善质量管理体系。
English:
Continuously improve the quality management system in accordance with the company's business and product development.
13. 中文:
履行加拿大 NHP Regulations 规定的 Quality Assurance Person 相关职责。
English:
Perform the duties and responsibilities of a Quality Assurance Person as required under the Canadian Natural Health Products Regulations.
任职要求Qualifications & Requirements必备条件Required Qualifications
中文:
- 药学、药物科学、化学、生物化学、食品科学、营养学、微生物学或其他相关专业背景;
- 具有 GMP、QA 或 QC 相关工作经验;
- 熟悉或愿意深入学习加拿大 Natural Health Products Regulations;
- 熟悉 NHP GMP、质量体系及质量文件管理;
- 能够审核 COA、原料规格、成品规格及质量记录;
- 具备良好的质量风险判断和问题解决能力;
- 具备良好的英文读写及专业沟通能力;
- 能够独立履行 QAP 职责,并对产品质量作出专业判断。
English:
- Educational background in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Food Science, Nutrition, Microbiology, or a related field;
- Relevant experience in GMP, Quality Assurance (QA), or Quality Control (QC);
- Familiarity with, or willingness to develop strong knowledge of, the Canadian Natural Health Products Regulations;
- Knowledge of NHP GMP, quality systems, and quality documentation;
- Ability to review COAs, raw material specifications, finished product specifications, and quality records;
- Strong quality risk assessment and problem-solving skills;
- Strong English written and verbal communication skills;
- Ability to independently perform QAP responsibilities and make skilled quality-related decisions.
优先考虑Preferred Qualifications 中文:
以下经验将优先考虑:
- 加拿大 NHP 行业工作经验;
- Health Canada NHP GMP / Site Licence 实际经验;
- NPN 产品质量管理经验;
- 保健品、天然健康产品或药品进口质量管理经验;
- GMP Auditor / Internal Auditor 培训或相关资格;
- 供应商审核及供应商质量管理经验;
- 质量管理体系建立和维护经验;
- Health Canada GMP Inspection 应对经验;
- 药剂师、药学、Pharmaceutical Sciences、Chemistry、Biochemistry 等专业背景。
English: Preference will be given to candidates with:
- Canadian NHP industry experience;
- Practical experience with Health Canada NHP GMP and/or Site Licence requirements;
- Experience with NPN-licensed products and quality management;
- Experience in quality management for imported health supplements, NHPs, or pharmaceutical products;
- GMP Auditor / Internal Auditor training or related qualifications;
- Supplier qualification and supplier quality management experience;
- Experience establishing and maintaining quality management systems;
- Experience supporting Health Canada GMP inspections;
- Educational background in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related discipline.
我们重视的能力What We Value 中文:
我们不要求候选人必须持有某一种特定的“QAP证书”。我们更加重视候选人是否真正具备与公司业务相匹配的:
教育背景 + 专业培训 + 实际工作经验 + 技术知识
并能够实际承担加拿大 NHP 企业 Quality Assurance Person 的职责。
English:
A specific “QAP certificate” is not necessarily required. We place greater emphasis on whether the candidate possesses the appropriate combination of:
Education + Professional Training + Practical Experience + Technical Knowledge and is capable of effectively performing the responsibilities of a Quality Assurance Person for a Canadian NHP business.
薪资及工作安排Compensation & Work Arrangement
中文:
薪资将根据候选人的教育背景、专业资质、GMP经验、NHP行业经验及实际 QAP 能力面议。
全职、兼职均可考虑。对于具有丰富 NHP GMP 和 Health Canada 经验的专业人士,可协商灵活的工作安排。
English:
Compensation will be commensurate with the candidate's educational background, professional qualifications, GMP experience, NHP industry experience, and demonstrated QAP capabilities.
Both full-time and part time arrangements will be considered. Versatile working arrangements may be available for candidates with extensive NHP GMP and Health Canada experience.
Pay: From $15.00 per hour
Expected hours: 15.0 – 28.0 per week
Work Location: In person
📌 质量保证负责人(Quality Assurance Person / QAP) (Calgary)
🏢 Dr. Attlee
📍 Calgary