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 7-9 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 in Packaging with minimum 6-8 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 7-9 Years of experience in the job discipline (e.g. Regulatory Affairs/Quality Assurance/Analytical science / Packaging, polymer and/or printing stream / Formulation science / material management and overall drug development and manufacturing process.
- Minimum 1+ year of experience in project management is desirable.
- Excellent command of written and spoken English and/or other languages as applicable.
- Technical proficiency with Microsoft Office suite of applications/ Document Management and publishing tools.
- GMP experience
- Working skills in computer applications including Word, Excel
- Quality mindset
- Open for change and improvement
- Ability to meet deadlines
- Detail-oriented with commitment to high level of data integrity and accuracy
- Able to work independently
- Good understanding of the pharmaceutical product life cycle.
- Good review skills and concern for quality.
- Capabilities to face internal and external Audit situation.
- Good understanding of regulatory requirements, good Pharmacovigilance practices, good documentation practices and ICH-GCP guidelines desirable.
- 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 7-9 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 in Packaging with minimum 7-9 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.
- Leadership, problem solving, interpersonal skills.
Physical Demands/Work Environment
- Physical demands: Available for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location.
- Work environment: Office environment or remote.
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