22 days old

Senior / QA Specialist (QC Support)

Pfizer
Tunas, MO 65764
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**Senior QA Specialist (QC Support):**

We are looking for individual who can work independently and have good interpersonal skill. The incumbent will have the responsibility for QA operational oversight for the site Quality Control (QC) and ensures overall quality integrity of the chemical and microbiological labs to support the testing, approval and release of API. The incumbent is also Quality approval for analytical and cleaning method validation/verification, laboratory procedures, and analytical reports etc and ensure adherence to site procedures and Global Quality Standard /regulatory requirements. The incumbent will also be the Quality approval for laboratory investigations/deviations and change controls related to laboratory.



POSITION SUMMARY:

The incumbent will establish, maintain, coordinate and support the Quality Systems Compliance such as Change Control, Deviation, Internal Audits, Regulatory Inspections and GMP Training to support the various business processes on site in full compliance with GMP predicate rules and company internal requirements.

Review and approve change control, deviation, various reports to ensure consistency with quality standards and quality of deliverables as and when required.



+ Drive quality culture and promote GMP compliance behaviors to the site.

+ Ensure site compliance to Quality Standards and ICH guidelines.

+ Provide oversight to the site GMP operations to ensure products produced in compliance with the Quality Standards.

+ Collaborate with cross functional teams to improve quality systems.

+ Understand regulatory expectations and support site inspection readiness.



POSITION RESPONSIBILITIES:

Responsibilities:



+ Review and approve GMP documentation and ensure their compliance to Quality Standards.

+ Ensure adherence to quality procedures, regulatory requirements and cGMPs.

+ Improve quality assurance systems, as necessary.

+ Review and approve deviations according to the site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/regulatory impact. Ensure issues are escalated according to the Quality Standards.

+ Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.

+ Support the maintenance of validated stated of GMP systems and processes.



Job Relate Requirements:



+ Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices (GDP), and other applicable regulations.

+ Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.

+ Previous Quality Assurance and GMP Compliance experience.

+ Demonstrated ability to interact effectively with management, auditors and regulators.

+ Ability to interact effectively in teams and facilitate team discussions.

+ Good knowledge of QC operation and processes is preferred.



Accountabilities:



+ Ensure compliance activities are carried out as per approved procedures and policies.

+ Reviewing and approving change controls and deviation investigations.

+ Reviewing and approving GMP documents, method validation protocol and reports



EDUCATION:

A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.

EXPERIENCE :

For Senior QA Specialist: A minimum of 5 years' experience in Quality Assurance role within the pharmaceutical industry



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Quality Assurance and Control



\#LI-PFE
Posted: 2021-03-31 Expires: 2021-05-01
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Senior / QA Specialist (QC Support)

Pfizer
Tunas, MO 65764

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