Senior Executive - Production

Job Overview

To ensure compliance with cGMP, regulatory standards, and internal quality systems by supporting and coordinating with the production and QA teams for timely and effective resolution of quality-related issues, documentation, and QMS activities

Reporting Structure

Sr Manager Production

Experience

4 - 5 years of experience in Quality Assurance / Production support roles in a regulated pharmaceutical environment.

Deviation & Regulatory Compliance

Work closely with the QA team to promptly address and resolve deviations, non-conformances, and regulatory concerns.Ensure that production operations comply with internal quality standards and external regulatory requirements.

QMS Management

Handle and manage key Quality Management System (QMS) tools, including:

Change Control

Deviation Investigations

OOS (Out of Specification)

OOT (Out of Trend)

CAPA (Corrective and Preventive Actions)

Ensure all records are closed within defined timelines with proper documentation.

Investigations & Root Cause Analysis

Conduct thorough investigations for deviations, incidents, and market complaints.Identify root causes and drive the implementation of corrective and preventive actions.

SOP & Documentation Control

Develop, implement, and enforce Standard Operating Procedures (SOPs) across all production units.Ensure consistency, traceability, and alignment with quality expectations.

Documentation Review

Read, review, and revise critical documents including:BMR (Batch Manufacturing Record)BECR (Batch Equipment Cleaning Record)MMF (Master Manufacturing Formula)SOPsProcess Development Reports

Batch Record & Document Control

Ensure proper control and reconciliation of BMRs and BECRs.Maintain documentation integrity, accuracy, and compliance.

System Evaluation

Review the implementation and efficiency of the quality and inspection systems to ensure continual improvement.

Reporting

Lead investigation reports and prepare detailed documentation for deviations, CAPAs, OOS, and OOT.

Support Functions

Assist in any other assignments delegated by the HOD or second-line manager.

Competencies

Qualifications

B.Pharm / M.Pharm / M.Sc. or equivalent in relevant discipline.

About Us

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.

About The Team

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.Job Info

• Job Identification 90441116
• Job Category Production
• Posting Date 07/30/2025, 08:19 AM
• Degree Level Master's Degree
• Job Schedule Full time
• Locations Piramal, Thane, Maharashtra, 400703, IN