天津招聘

Position Title: Senior QA Auditor
Reports To: Global QA Audit Manager
Job Summary:
Responsible for the overall regulatory, internal corporate and vendor audit programs including; audit scheduling, execution, reporting, follow-up and closure of internal corporate and external suppliers audits. Supports and contributes to the Corporate Quality Audit function as required. Acts as Lead Auditor for audit teams, particularly for corporate audit of Apotex sites. Perform Due Diligence visits/audits. Provide expert support to Apotex and suppliers sites to ensure successful Regulatory inspections.


Job Responsibilities:


1. In accordance with Apotex SOPs, lead and perform corporate quality audits of Apotex sites, prepare reports and meet with site quality and other department management to review audit findings and, as necessary, assist in the investigation of audit findings to determine root cause and corrective/preventive actions. Issue audit report, perform follow-up and close out corporate audits.

2. Coordinate and schedule supplier and service provider audits in accordance with Apotex SOPs and current GMPs. Lead and conduct supplier audits, issue audit reports, follow-up on responses CAPAs and close out supplier audits.

3. Perform Due Diligence visits/audits of potential new suppliers to Apotex, produce reports and provide recommendations regarding suitability and compliance of new suppliers. Propose any follow-up remediations or CAPAs relevant to the new supplier.

4. Develop and maintain effective relationships with external suppliers, contractors, and business partners as well as Apotex Site QA and other internal departments in order to ensure timely audits, communication, and resolutions to discovered deficiencies and/or concerns.

5. Make decisions and provides recommendations to senior management that have direct impact on Apotex site and supplier quality and subsequent commercial manufacturing operations and/or product supply. Take appropriate actions to ensure any remediations are implemented.

6. Responsible for suggesting/evaluating changes to the audit system, making changes to the system, working with departments within and outside QA to improve quality as related to the system, producing reports as required, and training personnel on the system. To ensure timely input of data into the Audit System.

7. Provide technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance.

8. Works with the management to ensure the continuous compliance, development and improvement of Apotex and vendor audit programs.

9. Provide information/insight on regulatory requirements and stay abreast of changes in regulatory environment/trends.

10. Identifies root cause to complex and/or broader problems - develops solutions and implements action plans to mitigate risks, informing and escalating as required.

11. Provide expert inspection and logistics support during inspections of Apotex sites by regulatory agencies and customers. Follow up and compile information to support response and commitments made in the response to inspection reports.

12. Prepare, update and review proposed changes to SOPs, as required.

13. Ensure that all work is performed in full compliance with current Good Manufacturing Practices, Good Laboratory Practices, Good Distribution Practices, Standard Operating Procedures, all regulatory requirements, and established safety standards.

14. Work independently, in a team or lead a team, either within QA or with various departments, to ensure that all work is completed in a timely fashion to meet business and Regulator needs.

15. Provide expert QA support to other departments and Apotex projects as required.

16. To mentor, coach and be a role model for Quality Auditors.

17. To be able to operate and audit within all global cultures.

18. Perform other duties as required.



Job Requirements:

· University degree in science or science-related field
· Minimum 10 years of relevant experience in the GMP Regulated industry, 5 years of which has been spent in Quality Assurance and 3 of which should have been in an auditing role.
· Preferably an industry recognised auditing qualification eg IRCA
· Excellent knowledge of current good manufacturing regulations as applicable to the pharmaceutical industry, specifically FDA and to include others (e.g. Health Canada, EU, ANVISA and other international regulations).
· Expertise in at least one specific area of sterile, biopharmaceuticals, medical devices is preferred.
· Have thorough knowledge and understanding of the ICH guidance documents
· Clear and concise written and verbal English communication
· Strong communication, interpersonal and organizational skills
· Knowledge of Word, Excel, Powerpoint and other Microsoft office programs
· Up to 60% travel required

奥贝泰克药物化学（天津）有限公司是加拿大 Apotex Inc.独资在中国建立的公司，是一个具有国际先进水平的医药原料药研发、中试和小批量生产中心。公司高度重视研发，相信技术是企业发展的推动力，愿为有志在制药行业发展的有机合成，化学工程，药物分析，药物化学，国际贸易等方面的人才提供展现你才能的舞台。
报名方式：
应聘职位人员请在信封上注明应聘职位并将中英文简历，各种能力证书复印件，身份证复印件，联系方式及近照一张寄至：
天津经济技术开发区海星街19号
奥贝泰克药物化学（天津）有限公司 人力资源部
邮编：300457
E-mail ：zhaopin@apotexpharmachemchina.com