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Junior Officer

2 weeks ago

Pithampur, Madhya Pradesh, India Lupin Full time ₹ 15,00,000 - ₹ 28,00,000 per year
Job Description

Join Lupin Limited in the role of Junior Officer within our Quality division, specializing in Validation activities. This position is integral to ensuring the highest standards in cleaning validation processes for Active Pharmaceutical Ingredient (API) facilities. Your primary responsibility will involve managing and executing comprehensive cleaning validation protocols to guarantee product safety and regulatory compliance.

Key responsibilities include:

  1. Conducting residue cleaning validation to verify the removal of contaminants from manufacturing equipment.
  2. Performing nitrosamine cleaning validation to monitor and control genotoxic impurities in line with current global regulatory expectations.
  3. Carrying out genotoxic cleaning validation studies to assess and mitigate the risk of harmful agents.
  4. Calculating Risk Priority Numbers (RPN) as part of Failure Mode and Effects Analysis (FMEA) to evaluate and prioritize risks in cleaning processes.
  5. Executing Campaign Effectiveness and Hold Time (CEHT) and Degradation Effectiveness and Hold Time (DEHT) studies to ensure product integrity and process reliability.
  6. Being responsible for the qualification and validation of facilities, equipment, utilities, areas, and HVAC systems to ensure adherence to Good Manufacturing Practices (GMP) and internal quality standards.
  7. Preparing detailed and accurate validation documentation, including protocols, reports, and compliance records to satisfy auditing and regulatory requirements.

In addition to technical expertise, the role demands a proactive approach to continuous improvement initiatives and collaboration across cross-functional teams to enhance process efficiency and safety.

Lupin Limited fosters an inclusive work culture that values innovation, quality, and the development of talent. This role provides an excellent opportunity to contribute to pharmaceutical quality assurance, while growing your career within a leading global organization.

Work Experience

Applicants should have 2 to 5 years of relevant experience in pharmaceutical cleaning validation or related quality assurance roles within a regulated environment. Experience in handling validation of facilities, equipment, and utilities in API manufacturing settings is highly desirable. Strong knowledge of cleaning validation principles, risk assessments, and regulatory expectations is essential.

Education
Graduation in Pharmacy Competencies
Strategic Agility Innovation & Creativity Customer Centricity Developing Talent Result Orientation Process Excellence Collaboration Stakeholder Management