1+ months

Validation Engineer /

Pfizer
Dalian


/









(GMP)(PQS)SOP





1. GMP(PQS)SOP

2. //

3.

4.

5.

SOP

6.



7.

GMPPQSSOP

8.



9.



10.



11.

OWN IT

12.

13. EHS

EHSEHS





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/



GMP



GMP









OFFICE













Position Title : Validation Process Engineer

Report to :Associated Validation Manager/Validation Supervisor

Department : Production Department

Location : PGS Dalian

Purpose

Under the specific guidance of associated validation manager and validation supervisor, according to the validation plan and production plan timely and correctly accomplish the organization, coordination and implementation of the validation project, ensure the production process and the product always in line with GMP, Pfizer quality standard (PQS) and the requirements of site SOP.

Responsibility scope

1. According to Pfizer quality standards (PQS) and Site SOP, be responsible for the validation work related to production.

2. Constantly to understand and master the pharmaceutical industry new dynamic/new technology/new methods, provide good technical services to improve the level of production technology.

3. Establish good communication channels internally and externally, organize and associate the implementation of validation projects, make sure the validation work finished smoothly.

4. Complete other work arranged by validation manager.

5. Documentation management

Establish and update the related validation file and SOP. Collating the validation document according to requirement then submit for archive. The whole process should meet the requirements of data integrity.

6. Validation implementation

Coordinate validation work schedule related to production, and follow up to verify the completion of the validation projects.

7. Product quality control

Ensure each part of production process meet the GMP requirements, Pfizer PQS and Site SOP requirements. Validation work meet the requirement of data integrity. Responsible for the related validation work in product life cycle. Prepare the related area validation annual review document.

8. Equipment maintenance and management

Responsible for the production equipment validation work, ensure the validated status of production equipment in life cycle.

9. New products, new equipment and new process

In order to ensure the implementation of new products, new equipment and new process, participate in new product validation and new equipment testing, implement the project validation plan and finish the plan on time.

10. Safety and sanitation

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

11. Team spirit

Carry out team building, build team unity to achieve team target, have the spirit of OWN IT.

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

13. EHS

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

Job requirements

Education/experience

Bachelor degree or above in Pharmaceutics or chemical or equivalent. At least 2 years hands-on experience working in pharmaceutical industries.

Special knowledge

GMP standard (local & international) Other national drug laws and regulations, labor law, environmental law, etc

Skill

Understand GMP and other related concepts;

Understand the concept and process of validation/verification, regulations and guidelines, etc. Know the statistics basic knowledge.

Have the basic knowledge for QC lab, production process and equipment.

Have good learning ability to accept new knowledge;

Good execution and communication ability, organization and coordination ability and team spirit and the analysis judgment ability.

Good command of English comprehensive ability, familiar with computer and OFFICE software operation.

Resource Managed

Financial indicators Associate the associated validation manager implement the validation project within budget. Non-financial indicators :

S u bordinate number



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.

Categories

Posted: 2019-07-25 Expires: 2019-10-25

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Validation Engineer /

Pfizer
Dalian

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