Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
Post : Specialist Quality
Job Description
• Complete all documentation in compliance with cGMP and GxP standards.
• Support review of data within the required turnaround time, including follow up and escalations as required supporting team KPIs
• Prepare reports, complete review and assign comments as applicable
• Operate with proficiency in job related computer applications e.g., GLIMs, Microsoft Office
• Demonstrate ability to navigate, understand and comply to company test specifications and Pharmacopeia.
• Maintain clear, accurate records associated with all day to day activities.
• Facilitate and drive effective communication to ensure success. Liaise effectively with external groups to ensure progress of sample data review. Collaborating with others by sharing your skill set and expertise.
• Support and participation in Internal Investigations
• Ensure that all Quality Systems within the department are adhered to on a daily basis.
• Ensure training is current for all job functions performed
• Problem solving to get to root cause of issues.
• Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections.
Candidate Profile
• ‘3 - 6 years’ experience in the Pharmaceutical, Biopharmaceuticals industry.
• Degree in Microbiology
• Good communication, interpersonal skills and ability to work across teams.
• Proven organizational skills and excellent attention to detail
• Knowledge of regulatory/code requirements to EU and US pharmacopoeia
• Proficiency in English, being able to speak, read and write with minimal difficulty.
• Proficiency in Microsoft Office and job-related computer applications required e.g., SAP, GLIM’s
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
• Demonstrated ability to drive the completion of tasks.
• Proven decision-making capability with accountability and responsibility.
• Demonstrated ability to solve problems.
Additional Information
Experience : 3 - 6 years
Qualification : Degree in Microbiology
Location : Pune, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th May 2024
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