Job Description :

JOB DESCRIPTION

1. Employee Details

Positions: DGM Quality Assurance

Department: Manufacturing Quality Assurance Formulations

Function: Operation Head QA

Job Location: Chennai (Tamil Nadu)

2. Primary function :

(Describe the primary purpose, objective and/or function of this job)

- 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.

3. Primary responsibilities & Duties :

(The personnel must be able to perform all of the following duties and responsibilities)

- 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

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

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

- 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.

- Ensure compliance to systems and written procedures of all cGMP activities

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

- Responsible for compliance with all applicable procedures / Organization quality standards in the Quality Operations Unit.

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

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

- Consistently act as a role model for the Organization Values.

- 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.

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

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

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

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

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

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

4. Education Background

(minimum education required by the personnel to perform the role)

- Bachelors or masters in pharma, science or engineering.

5. Experience Or Knowledge Required In The Discipline Or Function

- Minimum 15 years experience in manufacturing and packing of parenteral Dosages from a reputed pharmaceutical organizations with at least 6 years of managerial experience in handling multiple teams in quality function.

6. Knowledge (please check the description that most closely fits this role)

Tick () AppropriateMinimum level of knowledge required to fulfill role

- Very significant management experience in several businesses and most line and support functions combined with deep experience in one or more of the organizations most important line functions

- Broad and substantive management experience across several line and support functions or businesses, or recognized outside the organization as having paramount capability in a broader discipline/area of study

- Broad management experience across several functional areas or businesses or concentrated knowledge of a particular discipline; considered the organizations expert within a particular discipline

- Mastery of a specific professional discipline combining deep knowledge of theory and organizational practice or expertise across several different disciplines within a function or several different job areas across functions

- Advanced/well-developed skills and knowledge within a specific professional discipline involving the integration of theory and principles with organizational practices and precedents

- Broader knowledge of theory and principles within a professional discipline or advanced knowledge of specific technical/operational practices

- Specialized knowledge of specific commercial, technical, trades, or office operations areas

- Fundamental knowledge of basic work routines and standards sufficient to operate within narrow boundaries

Mobile No. 09042032331

K Ganapathi

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

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