Job Description

Business: Pharma Solutions
Department: Engineering
Location: Digwal
Travel: NA

Job Overview

To maintain the GMP & EHS Documentation related to E&M

Key Stakeholders: Internal

Production, QA, EHS

Key Stakeholders: External

Regulatory, Customer

Reporting Structure

AGM - E&M

Positions that report into this role

Executive/ Sr. Executive / Dy. Manager

Experience

12 years and above

:

Responsible for carrying preventive maintenance as per schedule. Should be capable of handling Quality, EHS Audits. Should have in-depth knowledge in cGMP/USFDA Documentation Should have in-depth knowledge in Current safety systems/safe working practices. Person should be capable to Train & lead the Team Should be familiar with online GMP documentation. Should be familiar with Root cause Analysis tools. Should have in-depth knowledge on Equipment Qualification, Preventive maintenance documentation, ISO documentation, SAP knowledge. Responsible for preparation of SOP's, HVAC protocols and validation reports. Should be familiar with Change controls, Deviations, Risk assessments Should be familiar with process equipment like Reactor, centrifuge, ANFD, RCVD, Blender, sifter, multi mill, FBD etc Should be familiar with Utility equipment like Boiler, Air compressor, nitrogen plant, chillers Responsible for preparation of all types of schedules and follow-up with user departments Responsible for Audit compliance, CAPA closing. Co-ordination with QA, production, EHS and Engineering team.

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.