Manager- Quality

Business: Piramal Pharma Solutions

Department: Quality

Location: Kurla

Travel: Low

Job Overview: Remote support to PPL sites in reviewing analytical data remotely, preparing master build in LIMS (Lab Vantage / Labware), Document Preparation (specifications, test methods, protocols, etc.) and uploading for review in ensure, initiating QMS elements in Trackwise / eDMS.

Key Stakeholders: Internal

Site Quality Team (QC, QA), Corporate Functions

Key Stakeholders: External

Regulators (during inspection), Solution Providers

Reporting Structure

PPL Site Quality (Functionally) and CQA Document, Data Review & Creation (Administratively)

Qualification

B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/Microbiology

Experience

• Need to be ready to live and embrace the Piramal values.

• Quality professional with 8+ years of QC / QA experience in a regulated pharma companies.

• Must have hands-on experience in Laboratory software's, testing, applications and systems (Chromatography By HPLC and GC, UV, IR, Dissolution, Malvern, KF auto titrator, etc).

• Must have worked in LIMS for Data entry / master build, and data review.

• Knowledge of applicable regulatory requirements / regulations (USFDA, EU, Health Canada, others).

• Need to be aware of latest regulations and pharmacopeial requirements.

• Well-organized and committed, with strong verbal and written communication skills. Good Collaboration skills and Team player.

Key Roles and Responsibilities:

• Preparation of Master Build in LIMS.

• Oversee track-wise operations for QMS activities.

• Preparation and review of Method Validation, Method Transfer, Method Verification, and Equivalency documents.

• Preparation and review of Test Methods, STPs, and Specifications.

• Operational knowledge of eDMS and ensure application compliance.

• Monitor compendial changes and prepare evaluation reports (including specifications and methods) for affected site products and materials.

• Review analytical data, raw data, chromatography, and LIMS for RM/PM/FP.

• Prepare and review new SOPs.

• Ensure timely completion of documentation.

• Maintain data integrity while preparing, uploading, or reviewing documents.

• Collaborate effectively across Piramal Plants.

• Provide support to any PPL site as required, with role assignments based on evolving needs and timelines.

• Perform activities across US, Canada, and EU time zones; available to travel for up to 3 months to PPL sites (India and overseas) as needed.

Perform additional tasks as assigned by the Leadership team based on requirements

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.