Regulatory Operations Specialist II
Job Description
Job Overview:
Responsible for the analytical support for the developmental projects/comparative dissolution projects and for the proper recording of information.
Summary of Responsibilities:
- Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from other Janssen sites.
Responsible to be an interface with contract laboratories, suppliers, customers and peers to define and improve project performance and expectations.
Responsible for to coordinate with CRO and ensure that project complete with in timeline.
Designs scientific experiments. Actively and personally monitor lab work. Recommends expansion or curtailment of investigations on the basis of experimental results or scientific information.
Responsible for the preparation of test methods, technical documents, protocols and reports whenever required
Is responsible for the proper recording of information. Ensures that records and raw data are properly retained. Summarizes, interprets, reviews data and draws conclusions.
Analyzing and drawing interpretation out of the dissolution data sets.
Trouble shooting the problems associated with instruments or methods.
Performing activities following the GMP/ safety requirements related to the assigned activity.
Multimedia Dissolution testing
Knowledge of Regulatory Guidelines on dissolution studies e.g. FDA-SUPAC and ICH for validations and other emerging market like China, Latin America
Knowledge of In vitro dissolution testing
Comparative dissolution testing including multimedia dissolution
Interface with Contract labs
Dissolution Investigations.
Basic knowledge on formulation (Oral solid dosage forms)
Participate in process improvement initiatives.
Work closely with clients to ensure client satisfaction, in transition and delivery and ensure delivery of services meets or exceeds Service Level Agreements.
Work closely with the Quality Assurance department at Fortrea to develop SOPs and training material and provide training as appropriate.
Assist in training and mentoring of the project team.
Implement process and productivity improvements as appropriate to improve operational efficiency.
Prepare and participate in audits, either by the client or a regulatory agency.
Consistently contributes to solving technical and/or operational problems identified by program/project members.
Working with company leadership to define project objectives, processes, policies, procedures and rules.
Well versed with product knowledge.
Participate in cross-functional meetings as needed.
Responsible for cascading relevant information from internal and external meetings to appropriate colleagues.
Assist with the generation, review and implementation of SOPs, Work Instructions, etc.
Is responsible for the proper recording of information. Ensures that records and raw data are properly retained.
Qualifications (Minimum Required):
- Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 4-7 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
- Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification with minimum 4-7 years of experience in packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
- Speaking-English and/or other languages as applicable.
Experience (Minimum Required):
- At least 4-7 Years of experience in the job discipline (e.g. Regulatory Affairs/ Quality Assurance/Analytical science / Packaging, polymer and/or printing stream / 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.
- Good organizational and time management ability.
- Good analytical capabilities and Customer focus.
- Good review skills and concern for quality.
- Good Communication and presentation skills
- Should a team player
- Decision making capabilities
- Good Collaborative skills
- Planning and execution
Preferred Qualifications Include:
- Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 4-7 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
- Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification with minimum 4-7 years of experience in packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
- Knowledge of Management Information System (MIS) and electronic data management system (eg: Regulatory Information Management, etc.) system will be preferred.
- Diploma or certification in Regulatory Affairs will be preferred.
- Interpersonal skills, Problem solving, Innovation and Proactive, taking ownership, Precise, Goal oriented.
- Leadership, problem solving, interpersonal skills.
Physical Demands/Work Environment:
- Physical demands: Available to travel as per business requirement.
- Work environment: Office environment or remote.
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