北京招聘

Main responsibilities:
1. Lead QA team and work with the other functions to fulfill the following responsibilities:
2. In conjunction with the Legal department act as the primary interface with regulatory and licensing government agencies. To ensure regulatory compliance, establish programs to maintain all licenses and registrations.
3. Organize internal and regulatory inspections. Act as the primary contact with the health authorities during site inspections, and interact with officers from government agencies. Compile the response report with input from responsible departments. Follow up to ensure that the corrective and preventive actions for the inspections are completed.
4. Review and approve GMP documents, such as SOPs, master batch records, material and product specifications, manufacturing process instructions and personnel training plans. Ensure that all GMP procedures are executed accordingly.
5.Establish and maintain a documentation management procedure that ensures all GMP documents are properly prepared, reviewed, approved, implemented, distributed, and archived, and that maintains traceability of GMP related documentation at all times.
6. Determine the disposition of raw materials, packaging components, intermediates, bulk products and finished products by thorough review of product batch records, test results, material test records, and any other documents impacting material disposition.
7. Ensure that rejected and waste materials are properly handled and secured to prevent use, and that the activities are approved and documented.
8. In the event of a quality control failure with a distributed product, conduct in-depth investigation, notify senior management, and initiate appropriate action (product hold or reject, market withdrawal, or full recall).
9. Review and approve label copy for technical accuracy and ensure that Legal has reviewed for regulatory compliance.
10. Investigate, with the functional departments, product quality failures, and non conformance issues, and ensure product quality, safety, efficacy, identity and regulatory compliance are properly evaluated and documented. Approve deviation and non conformance product disposition.
11. Handle products complaints, including quality related complaint investigations, follow up activities and closure. Perform trend analysis and provide recommendation for improvement.
12. Establish CAPA procedure and ensure that all CAPAs driven by deviation, non conformance, product complaint, quality review etc. are complete and implemented in a timely manner.
13. Review and approve product quality and regulatory compliance related change request. Ensure all changes are properly documented, reviewed, evaluated, approved and implemented.
14. Establish a supplier qualification and monitoring procedure, and ensure that all raw materials and components are purchased from qualified suppliers. Perform supplier performance review and on site audits with the support of purchasing, technical or other department as needed.
15. Establish appropriate control procedures at contract manufacturers, contract labs, and warehouses and, monitor the GMP performance. Support the compliance improvement efforts at these locations.
16. Audit the internal procedures used for operation, cleaning, and maintenance, of equipment and facilities, to ensure that they are followed.
17. Provide input to the development of product qualification protocols for use in both Shaklee and contract facilities, and review and approve final executed documents
18. Administer GMP training program, conduct training sessions as required, and maintain training database. Ensure that training for operational SOPs is complete and documented
19. Establish an internal audit program that requires review of all areas of the facility on a periodic basis

Position Requirements:
1. Minimum of 7 years of experience in Quality Assurance/Compliance, with management experience in the FD&C industry,
2. Bachelors degree or above in pharmaceutics, food, chemistry, microbiology etc.
3. Extensive knowledge of GMP regulations for FD&C products and corresponding industry standards.
4. Management experience in QA or related operational functions and interaction with Product Management, Legal, and Field Support Departments.
5. Excellent critical thinking, strategic and analytical skills as well as a holistic approach to problem solving and decision-making.
6. Ability to resolve complex technical and regulatory issues to support changing business requirements.
7. Ability to analyze present processes to accurately predict and manage future needs.
8. Must work well under pressure with excellent organizational skills and ability to perform multiple, overlapping tasks.
9. Proven competence in creating, administering, and managing budgets.
10. Positive attitude, excellent interpersonal and communication skills.
11. Knowledge of computers, word processing, spreadsheet and statistical programs.
12. Must possess excellent oral, written and listening skills in English.
13. Some travel, possibly at short notice, is required.

嘉康利公司始创于1956年，是美国声誉***、历史最悠久的直销公司之一，也是全美排名第一的天然营养品公司。
嘉康利公司总部设于美国加州旧金山湾区，并在中国、中国台湾、加拿大、墨西哥、日本、马来西亚、印度尼西亚、印度等9个国家和地区设立公司。
2005年嘉康利公司进驻北京，成立嘉康利（中国）日用品有限公司，注册资本八千万人民币，投资总额一亿六千万人民币。2007年获得中国政府颁发的直销牌照。到2013年3月底，嘉康利（中国）已拥有27家分公司和办事处，年销售额超过20亿元人民币。
嘉康利公司致力于公益环保事业，以改善人类健康与生活品质为目标，倡导与自然和谐共存、重视环保及回馈社会的理念，并致力于成为全球排名第一的天然营养补充食品公司。