Friday, May 8, 2026
Fortrea is Hiring for Regulatory Operation Specialist II position || Direct apply here
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 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.
- 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.
- 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).
- 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.
Enzene Biosciences Ltd hiring for QA position || Click here to apply now
Job Title: Executive – QA (DSQA)
Department: Quality Assurance
Experience: 2–6 Years
Qualification: M.Sc / M.Pharm
Location: Pune
Job Purpose
To ensure cGMP compliance at the shop floor for Drug Substance (DS) manufacturing through effective line clearance, documentation review, in-process oversight, and quality systems activities.
Key Responsibilities
- Perform manufacturing line clearance on the shop floor for DS activities .
- Ensure proper execution and compliance of in-process checks during manufacturing operations.
- Conduct routine GMP rounds at the Drug Substance facility and document observations.
- Review online batch manufacturing records (BMR) for accuracy, completeness, and compliance.
- Review and approve process validation protocols and reports , cleaning validation protocols and reports .
- Review and manage Standard Operating Procedures (SOPs) and other protocols/reports related to shop floor operations.
- Coordinate collection and submission of samples as per BMR, specifications, process validation, and stability protocols.
- Perform regular shop floor compliance rounds to ensure adherence to cGMP and follow up on corrective actions.
- Prepare and support Annual Product Quality Review (APQR/PQR) documents.
- Initiate and manage Change Control, Deviations, Incidents, and CAPA , including investigation support and timely closure.
- Participate in QMS investigations and root cause analysis.
- Ensure continuous cGMP compliance and regulatory readiness at the shop floor.
- Perform risk assessments for critical manufacturing and quality processes.
Skills & Competencies
- Strong knowledge of cGMP, QMS, and regulatory requirements
- Hands-on experience with DS/DP shop floor QA activities
- Understanding of process validation, cleaning validation, and in-process controls
- Experience in BMR review and documentation control
- Good analytical, investigation, and problem-solving skills
- Effective communication and coordination with cross-functional teams
Regulatory Exposure
- USFDA, EMA, WHO, and other global regulatory guidelines (preferred)
Subscribe to:
Posts (Atom)