Title:  Senior Manager, Analytical Research - QA

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-

1. Provide leadership and direction to group to ensure achievement of CMC Quality accountabilities and responsibilities.
2. To provide guidance for robust analytical method development to ensure decrease in method failures.
3. To support on pharmacopoeia updates and new regulations for analytical methods to ensure continual improvement of the quality system.
4. 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.
5. To ensure the complaint of Analytical Method Development activities related to Chemical Entities, API, Drug Product Formulations.
6. 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.
7. Developing procedures / system to ensure compliance of R&D function.
8. To provide technical support for Plant Analytical Trouble Shooting investigation and regulatory query response.
9. Expertise in Quality Risk Management Method & Tools (Like Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Heatmap, Fishbone etc).
10. Expertise in extractable and leachable study.

Travel Estimate

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).