Title:  Manager- CQC&P

Job Title: Manager- CQC&P

Title: Manager CQC&P

Grade: Manager

Department: Corporate Quality Compliance and Policies

Location: Vadodara

Reporting to: Sr. Manager, Corporate Quality Compliance and Policies

 Area of Expertise: Quality and Compliance, Quality Management Systems, Manufacturing Operations, Facility & Equipment Systems

Job Responsibilities:

• Author and fully manage the lifecycle (development, review, change control, execution, approval, effective status, training activities, revision, obsoletion etc.) of global documents.

• Oversee and drive implementation of global documents with regulated market site representatives in order to direct implementation, facilitate implementation and guide sites to overcome hurdles in implementation as required
• Support the CQC&P team to ensure that target dates for updates on Global document implementation to regulatory bodies, e.g. FDA, are met by timely preparation and site data collection
• Monitor progress of commitments made to regulatory bodies and consultants for Global document creation/revision to ensure that deadline dates are not exceeded
• Support         the       upgrade/enhancement           of         enterprise       electronic        systems   by    ensuring          timely communications to aid site preparedness, e.g. notification of approved status of system GSOPs,  to enable alignment of site readiness to Go-Live target dates
• Execute projects and initiatives to enhance processes, compliance and the global document collection e.g.           reduction/simplification/enhancement of Global documents
• Carry out effectiveness checks of Global document implementation e.g. performing spot checks on site/function procedures to assess alignment against the requirements in the Global Documents

Education and Job Qualification:

Minimum of Bachelor’s degree.

Excellent interpersonal and communication, both written and verbal skills.

Strong organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously while working independently or with others as needed.

A self-starter with a hands-on approach and a can-do attitude.

Minimum of five (5) years of experience within the pharmaceutical industry in quality function role. Experience of working in an international multicultural matrix organization.

Disclaimer:The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties

Job Title: Manager- CQC&P

Title: Manager CQC&P

Grade: Manager

Department: Corporate Quality Compliance and Policies

Location: Vadodara

Reporting to: Sr. Manager, Corporate Quality Compliance and Policies

 Area of Expertise: Quality and Compliance, Quality Management Systems, Manufacturing Operations, Facility & Equipment Systems

Job Responsibilities:

• Author and fully manage the lifecycle (development, review, change control, execution, approval, effective status, training activities, revision, obsoletion etc.) of global documents.

• Oversee and drive implementation of global documents with regulated market site representatives in order to direct implementation, facilitate implementation and guide sites to overcome hurdles in implementation as required
• Support the CQC&P team to ensure that target dates for updates on Global document implementation to regulatory bodies, e.g. FDA, are met by timely preparation and site data collection
• Monitor progress of commitments made to regulatory bodies and consultants for Global document creation/revision to ensure that deadline dates are not exceeded
• Support         the       upgrade/enhancement           of         enterprise       electronic        systems   by    ensuring          timely communications to aid site preparedness, e.g. notification of approved status of system GSOPs,  to enable alignment of site readiness to Go-Live target dates
• Execute projects and initiatives to enhance processes, compliance and the global document collection e.g.           reduction/simplification/enhancement of Global documents
• Carry out effectiveness checks of Global document implementation e.g. performing spot checks on site/function procedures to assess alignment against the requirements in the Global Documents

Education and Job Qualification:

Minimum of Bachelor’s degree.

Excellent interpersonal and communication, both written and verbal skills.

Strong organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously while working independently or with others as needed.

A self-starter with a hands-on approach and a can-do attitude.

Minimum of five (5) years of experience within the pharmaceutical industry in quality function role. Experience of working in an international multicultural matrix organization.

Disclaimer:The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties