Executive Manager – Operations

20 hours ago

Agra, Uttar Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 30,00,000
Production Leadership Role

A seasoned professional with 15 to 20 years of experience in Injectable and Solid Dose Manufacturing, Planning & Operation Management in a regulatory work environment.

  • Oversight of daily manufacturing and packaging operations to ensure adherence to policies and procedures.
  • Strategic planning to increase production, assets capacity and flexibility while minimizing unnecessary costs and maintaining quality standards.
  • Regulatory expertise in leadership roles for US-FDA, MHRA, Anvisa, and PICs.
  • Knowledge of Production Optimization, Resource Management, and quality and regulatory domains.
  • Adequate knowledge of product, process, and equipment.
  • Implementation of CAPAs committed to Regulatory agencies.
  • Process validation, cleaning, and equipment validation.
  • Development of systems and processes to track and optimize productivity and standards, metrics, and performance targets.
  • Training of production personnel for their job roles.
  • Preparation and establishment of production procedures as per regulatory requirements.
  • Maintenance and calibration activities for facility, equipment, and instruments.
  • Maintenance of requisite spares for uninterrupted production.
  • Establishment of hold time periods for in-process products and cleaned/un-cleaned equipment.
  • Manufacturing of products as per instructions and contemporaneous record-keeping.
  • Procedures for operation and cleaning of equipment.
  • Cleaning of facilities and equipment.
  • Storage of products as per storage conditions and environment monitoring records.
  • Cleanliness in change rooms and toilet facilities for production personnel.
Key Responsibilities
  • To prepare and establish production procedures as per regulatory requirements.
  • To ensure maintenance and calibration activities for facility, equipment and instruments.
  • To maintain requisite spares for un-interrupted production.
  • To establish hold time period for in-process product and cleaned/un-cleaned equipment
  • To ensure product is manufactured as per instructions and records are filled contemporaneously.
  • Ensure procedures are in place for operation and cleaning of equipment
  • To ensure cleaning of facility and equipment.
  • To ensure products are stored as per storage conditions and records of environment monitoring are maintained
  • To ensure cleanliness in change rooms and toilet facility for production personnel

Job Requirements:

A minimum of 15 years of experience in Injectable and Solid Dose Manufacturing, Planning & Operation Management in a regulatory work environment.

Responsibilities:

In addition to key responsibilities above, the successful candidate will be responsible for developing and implementing new systems and processes, leading cross-functional teams, and fostering a culture of continuous improvement.

We Offer:

A competitive salary and benefits package, including health insurance, retirement plan, and paid time off.

About Us:

We are a dynamic and innovative organization dedicated to delivering high-quality products and services to our customers.

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