Job Description :

We are hiring for the below profile for the Leading Global Pharmaceutical Giant.

Work Location: Chennai.

Designation : DGM - Manufacturing Quality Assurance ( Injectables)

Education : Bachelors or masters in pharma, science or engineering.

Experience : 16 to 20 years

Job Profile :

Primary Function :

To provide leadership to the operations quality team. To lead and guide all direct reports and team members providing coaching and mentoring to all direct reports. Responsible for the development and execution of the strategy and plan for the Quality Operations function. Responsible for providing direction to the functional area to ensure high-quality, safe and effective products and/or services compliant with regulatory expectations.

Primary responsibilities & Duties :

1) Responsible for directing the quality efforts of the applicable functional area in support of compliance and business objectives to ensure adequate talent and other resources are available to meet the challenges of the organization

2) Responsible for the quality oversight of the activities of all production units and Warehouse operations(incoming quality and dispatch) at site.

3) Responsible for the quality oversight of the engineering activities such as review of calibration records, PMP records, change controls and support investigations.

4) Ensure the compliance in the lab data derived from quality control (chemical quality and biological quality) analysis to the systems and written procedures through the Analytical Quality Assurance team.

5) Ensure compliance to systems and written procedures of all cGMP activities

6) Approval of written procedures / Validation protocols/ MMR and MPR etc.

7) Responsible for compliance with all applicable procedures / Pfizer quality standards in the Quality Operations Unit.

8) Lead the functional area as a quality and compliance decision maker to ensure the safety and effectiveness of the products, procedures, and services

9) Represent the Quality Operations organization to external stakeholders, including regulatory agencies and customer audits.

10) Consistently act as a role model for the Pfizer Values.

11) Set goals for the applicable functional area to improve and sustain compliance as well as advancing the business and scale the infrastructure to support business needs.

12) Maintain positive relationships internally and externally while fostering a culture of continuous improvement in the functional organization

13) Ensure the quality strategy is transparent and the organization is engaged on its execution

14) Monitor the performance of products and/or services and the quality system using appropriate metrics, and demonstrate a commitment to continuous improvement

15) Use quality and risk management tools to make timely decisions based on scientific knowledge that protects the customers and the brand.

16) Demonstrate confidence during difficult decision-making and influence business partners to ensure acceptable quality outcomes

17) Attract, retain and proactively develop a pipeline of key talent through coaching, training, experience development and internal/external recruitment

If you are really excited with above opportunity, kindly drop your profile or call @ 8072889969 / 7349117421

Sivaperuman.D.S

Associate Talent Acquisition

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance

Role Category:Senior Management

Role:Head/VP/GM-Quality Assurance/Quality Control

Employment Type: Permanent Job, Full Time

Keyskills

Quality Assurance Manufacturing Quality Injectables Quality Engineering investigational Approval Analytical Assurance Inprocess QA

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