Validation Supervisor

Jakarta - Indonesia

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Use Your Power for Purpose

Every day our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative flexible and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development maintenance compliance or research analysis your contributions have a direct impact on patient care.

What You Will Achieve

In this role you will:

Evaluate review and approve validation master plans protocols and reports ensuring compliance with company standards and regulatory requirements.
Troubleshoot validation issues for equipment and performance processes providing expertise for resolution.
Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
Guide the writing review and approval of validation process documents and technical reports ensuring adherence to the latest Pfizer Quality Standards.
Contribute to moderately complex projects manage time effectively and develop plans for short-term work activities.
Manage routine quality systems such as Change Control Documentation and Investigations and coordinate testing with functional groups.
Maintain the Site Validation Master Plan support regulatory audits and represent validation on site or network teams.
Support product transfers/new product development regulatory queries and cost improvement projects.
Ensuring integration of validation schedules in production and participating in deviation investigations.
Maintain and manage of Continued process verification (CPV) and Periodic Cleaning Monitoring (PCM)

Here Is What You Need (Minimum Requirements)

You hold a degree in pharmacy pharmaceutical technology or comparable scientific discipline.
Minimum two years of experience in pharmaceutical industries combined with strong knowledge of regulatory requirements GMP and pharmaceutical development processes.
Strong technical knowledge with validation/qualification of pharmaceutical processes equipment utilities facilities and/or computer systems
Excellent verbal and written communication skills
Ability to work independently and in a team environment
Ability to work under pressure and adapt to a fast-paced environment
Strong analytical and problem-solving skills
Strong organizational and time management skills
Willing to be placed in Jakarta

Bonus Points If You Have

Strong working knowledge of various quality systems and processes
Ability to mentor and guide other colleagues
Experience with Solid Oral Dosage/Semi-Solid Dosage/Liquids Dosage forms
Lean Six Sigma Yellow Belt or Green Belt certification

Work Location Assignment:On Premise

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

Required Experience:

Manager

Use Your Power for PurposeEvery day our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative flexible and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development maintenance complianc...

Use Your Power for Purpose

What You Will Achieve

In this role you will:

Evaluate review and approve validation master plans protocols and reports ensuring compliance with company standards and regulatory requirements.
Troubleshoot validation issues for equipment and performance processes providing expertise for resolution.
Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
Guide the writing review and approval of validation process documents and technical reports ensuring adherence to the latest Pfizer Quality Standards.
Contribute to moderately complex projects manage time effectively and develop plans for short-term work activities.
Manage routine quality systems such as Change Control Documentation and Investigations and coordinate testing with functional groups.
Maintain the Site Validation Master Plan support regulatory audits and represent validation on site or network teams.
Support product transfers/new product development regulatory queries and cost improvement projects.
Ensuring integration of validation schedules in production and participating in deviation investigations.
Maintain and manage of Continued process verification (CPV) and Periodic Cleaning Monitoring (PCM)

Here Is What You Need (Minimum Requirements)

You hold a degree in pharmacy pharmaceutical technology or comparable scientific discipline.
Minimum two years of experience in pharmaceutical industries combined with strong knowledge of regulatory requirements GMP and pharmaceutical development processes.
Strong technical knowledge with validation/qualification of pharmaceutical processes equipment utilities facilities and/or computer systems
Excellent verbal and written communication skills
Ability to work independently and in a team environment
Ability to work under pressure and adapt to a fast-paced environment
Strong analytical and problem-solving skills
Strong organizational and time management skills
Willing to be placed in Jakarta

Bonus Points If You Have

Strong working knowledge of various quality systems and processes
Ability to mentor and guide other colleagues
Experience with Solid Oral Dosage/Semi-Solid Dosage/Liquids Dosage forms
Lean Six Sigma Yellow Belt or Green Belt certification

Work Location Assignment:On Premise

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

Required Experience:

Manager

Key Skills

Python
SOC
Debugging
C/C++
FDA Regulations
Minitab
Technical Writing
GAMP
OS Kernels
Perl
cGMP
Manufacturing

Apply Now

About Company

Pfizer

Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.

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