Job Overview:
Responsible for creation/revision/compilation/approval of Specifications/Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable.
Summary of Responsibilities:
• Responsible to follow GMP and safety practices in the organization.
• Analysis of Assay, Related substances, Laser Particle size and Residual solvents of API.
• Analysis of Assay, Related substances, Dissolution, Blend Uniformity, Content Uniformity of Finished products.
• Responsible for complainace of GLP & GDP, cGMP- Guideline & ICH Guidelines.
• Analysis of cleaning validation and process validation.
• Responsible to perform the task assigned by the HOD as and when required.
• Skilled at handling instruments such as pH meter analytical balance, Karl Fisher, UPLC, GC, HPLC, Dissolution, Particle size Analyser etc.
• Maintain training related documentation as per Fortrea and client requirements.
• Support with onboarding, training and mentoring new associates.
• Other duties as assigned by management.
Qualifications (Minimum Required):
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Bachelor’s in Pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) as applicable.
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Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
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Speaking-English and/or other languages as applicable.
Experience (Minimum Required):
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0-3 Years of experience in the job discipline (e.g. Regulatory Affairs/Quality Assurance/Analytical science / Pharmaceutics / material management and overall drug development and manufacturing process).
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Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
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Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable.
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Interpersonal skills, Proactive, Taking ownership, Precise, Goal oriented.
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Good organizational and time management ability.
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Good analytical capabilities and Customer focus.
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Good review skills and concern for quality.
Preferred Qualifications Include:
• Bachelor’s in pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) with 0-1 years of relevant experience.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Knowledge of Management Information System (MIS) and electronic data management system (e.g: Regulatory Information Management, etc.) system will be preferred.
• Diploma or Certification in Regulatory Affairs will be preferred.
Physical Demands/Work Environment:
• Physical demands: No special factor at this time.
• Work environment: Office environment or remote.
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