Title:  Senior Executive

Position:

Sr. Executive

Job Grade:

G11B

Job Title:

Analytical Research - QA

Sub-function:

CMC - QA

Manager’s Job Title:

Sr. Manager - II

Skip Level Manager’s Title:

DGM

Function Head Title:

AVP (RnD Quality Head)

Location:

Vadodara

Areas of Responsibility

This position is responsible for:

• Developing procedures / system and for assuring compliance of the R&D function.
• Ensure the Compliant of analytical method validation/verification of Excipient, intermediates, Drug substance, Drug Product and technology transfers to the manufacturer organisation.
• To draft, review guidelines /SOPs/Protocols/Reports associated with the product development.
• To review and assess data based on Analytical QBD based approach. To ensure analytical development data supports to robust test method and suitable to entire product lifecycle.
• To review and approve of QMS like change control, deviation, events, OOC, CAPA for cGxP compliance and centralised QA oversight for Analytical Development Department.
• To review and approve of Plant Trouble Shooting Report and Analytical technical report to support Agency query and/or site investigation.
• Expertise in Quality Risk Management Method & Tools (Like Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Heatmap, Fishbone etc).
• To review and approve Standard Test Procedure and specification.
• To have understanding on the pharmacopeial compliance
• Review and approve the extractable and leachable study reports.

Job Requirements

Educational Qualification

M. Sc/ M. Pharm

Specific Certification

NA

Skills

Understanding of CGMP

To understand and interpretation of 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, Rehometer etc.

Communication skill

Prioritization according business requirement.

Experience

6-10 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).