Executive

The Executive - QA Department will manage DRA, quality assurance documentation, regulatory affairs support, product documentation, compliance tracking, and QA coordination at Helios, Ahmedabad. This requires graduate or post graduate qualification with 6–8 years of experience in DRA, quality assurance, documentation, and regulatory affairs.

Roles & Responsibilities

• Prepare and review regulatory documents, product dossiers, technical files, and QA submission records.
• Coordinate documentation for product registration, renewal, variation, and regulatory compliance requirements.
• Support QA documentation, specification review, stability data, validation documents, and batch-related records.
• Coordinate with QA, QC, production, packaging, R&D, warehouse, and management teams for regulatory data.
• Maintain regulatory trackers, submission records, approval files, query responses, and compliance documents.
• Review documents for accuracy, completeness, data integrity, and regulatory alignment.
• Support response preparation for regulatory queries, customer requirements, and audit observations.
• Ensure documentation follows applicable regulatory guidelines, company SOPs, and quality standards.
• Track regulatory timelines, pending documents, product approvals, and compliance updates.
• Maintain confidentiality of product, technical, and regulatory information.
• Support audits, inspections, and regulatory readiness activities.
• Ensure timely, accurate, and compliant QA and regulatory affairs support.

Helios Pharmaceuticals is a leading Indian pharmaceutical company dedicated to promoting "Good Health Since 1985." Established in 1985, the company has built a strong reputation in the pharmaceutical industry through its commitment to quality manufacturing, innovation, and customer satisfaction. Headquartered in Ahmedabad, Gujarat, Helios Pharmaceuticals operates across India with a diverse portfolio of pharmaceutical products and contract manufacturing services.

Helios Pharmaceuticals is a subsidiary of the 90-year-old privately held company P.K.T.P. Private Limited and has grown into a trusted partner for many leading pharmaceutical companies in India and overseas. The company specializes in pharmaceutical manufacturing, ethical products, generic medicines, and third-party manufacturing services.

Our Vision

To strive for excellence, achieve the highest levels of customer satisfaction, and create a challenging and motivating environment that inspires employees to excel. Helios aims to become a frontrunner in the pharmaceutical industry through continuous growth and innovation.

Our Mission

• To manufacture high-quality pharmaceutical products that meet international standards.
• To ensure customer satisfaction through excellence in quality and service.
• To continuously innovate and improve manufacturing processes.
• To build long-term partnerships with customers and healthcare organizations.
• To contribute towards improving global healthcare outcomes.

Manufacturing Excellence

Helios Pharmaceuticals operates a state-of-the-art manufacturing facility located in Baddi, Himachal Pradesh, approximately 40 kilometers from Chandigarh. Spread across 18,000 square meters with a built-up area of 6,000 square meters, the facility complies with Revised Schedule M and WHO-GMP standards and is designed for future upgrades to meet US FDA requirements.

The manufacturing facility is equipped to produce:

• Tablets
• Capsules
• Ointments
• Creams
• Gels
• Lotions
• Topical formulations

The plant has an annual manufacturing capacity of approximately:

• 60 million tablets
• 5 million capsules
• 2 million topical products
• 1 million lotion units

Quality Assurance

Quality remains the cornerstone of Helios Pharmaceuticals' operations. The company maintains a sophisticated Quality Control and Quality Assurance Department equipped with advanced analytical instruments and follows strict documentation practices, including SOPs, calibration records, and validation procedures to ensure product safety and efficacy.

Research and Development

Helios Pharmaceuticals invests in research and formulation development to optimize existing products, improve manufacturing processes, and develop innovative pharmaceutical formulations. The company's dedicated R&D laboratory supports continuous product enhancement and new product development initiatives.

Trusted Manufacturing Partner

Helios Pharmaceuticals serves as a contract manufacturing partner for several leading pharmaceutical companies, including:

• Abbott
• Sandoz
• Dr. Reddy's Laboratories
• Sun Pharmaceutical Industries
• Torrent Pharmaceuticals
• Intas Pharmaceuticals
• Alembic Pharmaceuticals
• USV Private Limited
• Glenmark Pharmaceuticals
• Alkem Laboratories

The company has also expanded its presence internationally, exporting products to markets in the Middle East, Africa, and Southeast Asia.

Why Choose Helios Pharmaceuticals?

• Nearly four decades of pharmaceutical expertise
• WHO-GMP compliant manufacturing facilities
• Strong quality assurance systems
• Diverse pharmaceutical product portfolio
• Trusted contract manufacturing partner
• Dedicated research and development capabilities
• Growing international presence
• Customer-focused approach and ethical business practices

Our Commitment

At Helios Pharmaceuticals, the commitment to healthcare goes beyond manufacturing medicines. The company strives to improve lives by delivering safe, effective, and affordable pharmaceutical products while maintaining the highest standards of quality, integrity, and customer service.