Executive - Regulatory Affairs (Piramal)

Roles and Responsibilities

Job Overview

We are looking for a RA- Executive to join our team. The role will be responsible the role also includes participation in investigations such as deviations, OOS/OOT, and supporting departmental responsibilities in the absence of the reporting authority, along with any duties assigned by seniors.

Key Responsibilities:

• To prepare, review and update SOP, Specification, Method of analysis, Report and Protocols.

• To review 10. OQ. PQ of new instrument.

• To attend the trouble shooting of QC instruments and to co-ordinate with the authorized supplier for support if any.

• To maintain, execute and update calibration and validation schedule of all QC instrument.

• To ensure that GLP practices are followed in QC department.

• Handling change control related documentation in QC department.

• Monitoring the procedures related to Laboratory management is followed as per SOP.

• Involved in investigations like Deviation, ODS and OOT

• To handle the responsibilities of reporting authority in his/her absence.

Preferred candidate profile:

• Masters/bachelor’s degree in chemistry or a related field.

• Basic understanding of peptide synthesis principles is a plus.

• Strong attention to detail and commitment to quality.

• Ability to work in a team-oriented environment.

• Good communication and interpersonal skills.

• Willingness to learn and adapt to new processes.

Qualifications

Masters/bachelor’s degree in chemistry or a related field.