Engineering - Senior Executive - Documentation/Qms

The Senior Executive – Engineering Documentation will play a critical in maintaining precise technical records for all engineering activities, utility operations, maintenance, and plant processes. The ensures proper documentation for audits, compliance, and operational efficiency while supporting cross-functional engineering and production teams.

Roles and Responsibilities:

• Develop, maintain, and update engineering documentation, including SOPs, maintenance logs, equipment manuals, and calibration records.
• Ensure all engineering records are accurate, complete, and aligned with GMP, GLP, and regulatory compliance standards.
• Maintain documentation for preventive and corrective maintenance activities across plant utilities, machinery, and process equipment.
• Coordinate with maintenance, production, and QA teams to collect, review, and archive technical reports and maintenance records.
• Support the creation and management of equipment qualification documentation (IQ, OQ, PQ) and validation records.
• Prepare technical reports for audits, regulatory inspections, and internal reviews, ensuring timely submission and correctness.
• Review engineering change controls, deviation reports, and CAPA documentation to ensure proper recording and traceability.
• Monitor documentation workflows to ensure timely approvals, revisions, and version control.
• Maintain records of energy audits, utility monitoring, and equipment performance metrics for management review.
• Assist in training junior staff on proper documentation practices and SOP adherence.
• Ensure compliance with document retention policies, archiving standards, and regulatory requirements.
• Participate in audits and inspections, providing all required engineering and maintenance documentation to auditors.
• Collaborate with cross-functional teams to prepare reports for new equipment installation, commissioning, and qualification.
• Track and update all preventive maintenance schedules, breakdown reports, and equipment history in digital and manual systems.
• Ensure proper documentation of safety checks, equipment calibrations, and utility monitoring logs.
• Continuously improve documentation systems, workflows, and templates for efficiency, accuracy, and compliance.
• Assist in reporting technical KPIs, equipment downtime analysis, and maintenance efficiency metrics.
• Support project documentation for process improvements, equipment upgrades, and new product trials.
• Maintain confidentiality of sensitive technical and operational data.
• Act as a liaison between Engineering, Production, QA, and Regulatory teams to ensure all documentation is aligned with operational and compliance requirements.

USV Private Limited is an Indian pharmaceutical company dedicated to delivering high-quality medicines and healthcare solutions. With a strong focus on innovation, research, and patient care, the company serves both domestic and global markets.

Our Story

USV began its journey with a vision to provide reliable and effective healthcare solutions. Over the years, the company has grown into a well-established pharmaceutical organization known for its commitment to quality and innovation.

Through continuous investment in research and development, USV has strengthened its capabilities in delivering advanced formulations and improving patient outcomes.

Our Mission

• To provide high-quality and affordable healthcare solutions
• To enhance patient outcomes through innovation and research
• To maintain excellence in pharmaceutical manufacturing
• To build long-term trust with healthcare professionals and patients

Our Vision

To be a trusted global pharmaceutical company recognized for quality, innovation, and patient-centric healthcare solutions.

Our Services / What We Offer

USV Private Limited offers a wide range of pharmaceutical solutions, including:

• Development and manufacturing of pharmaceutical formulations
• Research-driven healthcare products
• Solutions across multiple therapeutic segments
• Global distribution of medicines

Why Choose Us

• Strong focus on research and innovation
• Commitment to quality and compliance
• Trusted presence in domestic and international markets
• Patient-centric approach to healthcare
• Continuous improvement in products and processes

Our Team

USV is supported by a team of experienced professionals, scientists, and healthcare experts who are dedicated to delivering high-quality pharmaceutical solutions and advancing medical science.

Infrastructure / Technology

The company operates advanced manufacturing and research facilities designed to meet global quality standards. Its infrastructure supports innovation, efficiency, and consistent product quality.

Our Commitment

USV Private Limited is committed to improving healthcare by delivering safe, effective, and affordable medicines. The company emphasizes ethical practices, innovation, and quality in all aspects of its operations.