Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For over 175 years our brands and imprints have been a trusted source of knowledge to these communities and today, more than ever, we see it as our responsibility to ensure that fundamental knowledge can be found, verified, understood and used by our communities – enabling them to improve outcomes, make progress, and benefit the generations that follow.
Post : Process & Quality Analyst - Grade I
Job Description
• Perform quality checks of Drug profiles processed from various sources and provide timely feedback to the respective team member(s)
• Schedule weekly discussions with team members to address quality issues and new updates related to process
• Ensure that process related queries by trainees and accredited writers are addressed effectively
• Participate in the quality related discussion with relevant stakeholders on a regular basis
• Facilitate new hire trainings and refreshers
• Ensure periodic review and update of documentation related to quality and training based on customer feedback and product updates
• Ensure CAPAs for Non-Compliance issues identified within the team are completed within timeline
• Suggest process improvements to enhance quality of work
• To perform quality review of deliverables by applying internal guidance/SOPs; so as to ensure that the deliverable meets quality standard/customer requirements
• To provide training session for new joiners and refresher session for team
• Handle internal team queries as well as customer queries
• To provide process related updates to team and update the reference documents (SOPs/guidelines)
• Responsibility of / Expectations from the Role:
• To ensure quality of deliverables by applying technical knowledge, internal guidance/SOPs and customer requirements.
• Handle internal and customer related queries.
• To provide process related updates to team and update the reference documents (SOPs/user aid).
• To work towards improving and maintaining quality standards of the product
Technical Competencies :
• Sound knowledge of Clinical Research and Drug Development Life-cycle
• Knowledge of drug approval process, including regulatory guidelines
• Hands on experience with Database
• Literature reviewing and evaluation capabilities
• Good Command on verbal and written communication skills
• Planning & Prioritizing
• Good interpretation and analytical skills
• Coaching & Mentoring
Candidate Profile
B.Pharm, M.Pharm, B.Tech/ M.Tech.(Life sciences), M.Sc./B.Sc. (Life science), BDS, BHMS, BAMS, Ph.D. (Pharma/ Life science)
At least 24 months of experience in the current (Scientific and Medical Writing) role
Additional Information
Experience : 24 months of experience
Qualification : B.Pharm, M.Pharm, B.Tech/ M.Tech.(Lifesciences), M.Sc./B.Sc. (Life science), BDS, BHMS, BAMS, Ph.D
Location : Pune
Industry Type : Pharma
End Date : 30th August, 2022
See All B.Pharm Alerts M.Pharm Alerts Ph.D Alerts M.Sc Alerts
See All Other Jobs in our Database