Executive - Regulatory Affairs at Piramal

Thane, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

30 Apr, 26

Salary

0.0

Posted On

30 Jan, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, SOP Preparation, Quality Control, Calibration, Validation, GLP Practices, Change Control, Teamwork, Communication, Interpersonal Skills, Attention to Detail, Peptide Synthesis, Troubleshooting, Documentation, Investigations, Adaptability

Industry

Financial Services

Description

Business: PPL Department: Regulatory Affairs Location: Navi Mumbai Travel: Low 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. In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.

Responsibilities

The Executive in Regulatory Affairs will prepare, review, and update SOPs, specifications, and protocols, while also participating in investigations related to deviations and OOS/OOT. Additionally, the role includes maintaining QC instruments and ensuring compliance with GLP practices.