Regulatory operations assistant 1 (Fortrea)

Roles and Responsibilities

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):

• Bachelor’s in Pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) as applicable.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

• Speaking-English and/or other languages as applicable.

Experience (Minimum Required):

• 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).

• Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.

• Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable.

• Interpersonal skills, Proactive, Taking ownership, Precise, Goal oriented.

• Good organizational and time management ability.

• Good analytical capabilities and Customer focus.

• 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.