1+ months

Asso. Validation Mgr./

Pfizer
Dalian
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(GMP)(PQS)SOP





1. GMP(PQS)SOP

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GMPPQSSOP

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OWN IT

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15. EHS

EHSEHS

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GMP























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Position Title: Asso. Validation Manager

Report to : Production Director

Department : Production Department

Location :PGS Dalian



Purpose

Under the specific guidance of SQRT in the factory and the production director, validation manager is responsible for the quality standard according to Pfizer (PQS) and factory work requirements, is responsible for organizing, coordinating and plant validation work, management of validation documents, data, files, to ensure the smooth operation of the production quality system operation to provide support and services.



Responsibility scope

1. According to Pfizer quality standard (PQS) and SOP requirements, manage and responsible for the production related validation

2. To understand and master the pharmaceutical industry trends / new process / method, provide good technical services to improve the technical level of production

3. Internal and external to establish good communication channels, so that the verification work carried out smoothly.

4. Finish other work arranged by department director.

5. Document Management

Ensure the whole process should meet the requirements of data integrity. Review and approval the validation document.

6. Validation implementation

Manage each area validation schedule, and track the completion validation project.

7. Quality Control

Ensure in the validation process each step follows the compliance and GMP, and obeys the PQS/SOP requirements. Responsible for validation system, and DI requirement for validation activities. Check the annual validation review document.

8. Equipment maintenance and management

Supervise the equipment validation; ensure equipment qualification state in the life cycle.

9. New products, new equipment and new process

Support the implementation of new products, new equipment and new process, manage the new product validation and new equipment C&Q, control the project validation schedule to ensure complete on time. Manage the related validation activities for product life cycle.

10. Safety and Hygiene

Ensure the safety of validation project implementation, maintain the clean environment of production, meet the requirement of GMP and site SOP.

11. Continues improvement

Support CI project to meet the site development requirements.

12. Team Building

To create a harmonious atmosphere of the team, encourage employees to develop and enhance the employee's sense of ownership, leadership staff to cope with various challenges. Have the spirit of OWN IT.

13. Training and people development

Develop training plan and procedure, employees can get effective training before working, improve the self-learning ability, guide the staff to complete the verification project independently.

14. Colleague Management

Proceed the performance management according to the employee rules.

15. EHS

Comply with company EHS policy and regulation, and complete the EHS related work.

16. Ensure that behavior in line with the requirements of national laws, regulations, policies



Job requirements

Education/experience

Bachelor degree or above, major in medical and drugs

At least 5 years' experience in pharma company. Strong knowledge in production process, utility system and laboratory management.

Special knowledge

Pharmaceutical process and equipment, Statistics skill.

Skill

Well-understand GMP and other related concepts;

Well-understand the concept and procedure of validation/verification, regulations and guidelines, etc. Know the statistics basic knowledge.

Understand QC lab and DP process knowledge.

Good leadership, communication ability and the coordinated ability; training ability.

Good text organization ability, good language (English and Chinese) communication skills, proficiency in the use of computer and related software

To master the advanced professional and technical knowledge and ability to learn

High responsibility and good occupation morality

With high job responsibility and good professional ethics

Complete the multiple tasks in the same time



Resource Managed

Financial indicators Associate the production director implement the validation project within budget.

Non-financial indicators

Subordinate number5



C:Plant Clock Standard - (China)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-09-04 Expires: 2020-03-08

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Asso. Validation Mgr./

Pfizer
Dalian

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