Senior Manager, Analytical Research - QA
SUN PHARMA
Date: 1 week ago
City: Vadodara, Gujarat
Contract type: Full time
Position
Sr. Manager – II
Job Grade
G9B
Job Title
Senior Manager, Analytical Research – QA
Sub-function
CMC - QA
Manager’s Job Title
DGM
Skip Level Manager’s Title
AVP (RnD Quality Head)
Function Head Title
AVP (RnD Quality Head)
Location:
Vadodara
No. of Direct Reports (if any)
6
Areas of Responsibility
This position is responsible for-
NA
Job Scope
Internal Interactions (within the organization)
Yes
External Interactions (outside the organization)
Yes
Job Requirements
Educational Qualification
M. Sc/ M. Pharm
Specific Certification
NA
Skills
Understanding of CGMP required.
Good Communication skill with good convincing power.
To have critical thinking approach & deep evaluation on subject on time to support leadership to derive right and faster decision to meet organisation’s need.
Excellent Managerial Skill and positive approach
To understand and interpret the data of sophisticated analytical instruments like HPLC, GC, IC, SEM, TEM, Auto-titrator, UV spectrophotometer, FTIR, Particle size analyzer, ICP-MS, LC-MS, GC-MS, HRMS, XRD, DSC, Dissolution, Viscometer, Rheometer etc.
Prioritization according business requirement.
Experience
15 -25 years
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 commensurate with the experience and background of incumbent(s).
Sr. Manager – II
Job Grade
G9B
Job Title
Senior Manager, Analytical Research – QA
Sub-function
CMC - QA
Manager’s Job Title
DGM
Skip Level Manager’s Title
AVP (RnD Quality Head)
Function Head Title
AVP (RnD Quality Head)
Location:
Vadodara
No. of Direct Reports (if any)
6
Areas of Responsibility
This position is responsible for-
- Provide leadership and direction to group to ensure achievement of CMC Quality accountabilities and responsibilities.
- To provide guidance for robust analytical method development to ensure decrease in method failures.
- To support on pharmacopoeia updates and new regulations for analytical methods to ensure continual improvement of the quality system.
- To lead, manage and motivate people with a variety of skill sets. Strong organizational, interpersonal and communication skills are essential. Use excellent negotiation and interpersonal skills to communicate effectively with all levels of the organization and external stakeholders.
- To ensure the complaint of Analytical Method Development activities related to Chemical Entities, API, Drug Product Formulations.
- To assure that Method Validation / Method Qualification / Method Transfer data are reviewed adequately within time and verify scientific rigor, adequacy, and completeness. Take active participation in the trouble shooting.
- Developing procedures / system to ensure compliance of R&D function.
- To provide technical support for Plant Analytical Trouble Shooting investigation and regulatory query response.
- Expertise in Quality Risk Management Method & Tools (Like Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Heatmap, Fishbone etc).
- Expertise in extractable and leachable study.
NA
Job Scope
Internal Interactions (within the organization)
Yes
External Interactions (outside the organization)
Yes
Job Requirements
Educational Qualification
M. Sc/ M. Pharm
Specific Certification
NA
Skills
Understanding of CGMP required.
Good Communication skill with good convincing power.
To have critical thinking approach & deep evaluation on subject on time to support leadership to derive right and faster decision to meet organisation’s need.
Excellent Managerial Skill and positive approach
To understand and interpret the data of sophisticated analytical instruments like HPLC, GC, IC, SEM, TEM, Auto-titrator, UV spectrophotometer, FTIR, Particle size analyzer, ICP-MS, LC-MS, GC-MS, HRMS, XRD, DSC, Dissolution, Viscometer, Rheometer etc.
Prioritization according business requirement.
Experience
15 -25 years
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 commensurate with the experience and background of incumbent(s).
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