质量保证负责人(Quality Assurance Person / QAP) (Calgary)

质量保证负责人(Quality Assurance Person / QAP) (Calgary)

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

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