Process & Quality Analyst – Grade I
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We’re looking for Process & Quality Analyst – Grade I to join our team at Springer Nature. The job is based in Pune, Maharashtra and you will be working with team members and stakeholders in London/Berlin.
Springer Nature Technology and Publishing Solutions, is the technology and publishing solutions arm of the Springer Nature Group. We leverage our insight in the publishing domain and acquire, produce and deliver content across media and markets using our Technology and Publishing Solutions. With a focus on technology driven solutions and deep insight in the publishing domain, Springer Nature Technology and Publishing Solutions offers a range of services that help our Group brand acquire, produce and deliver content in the most efficient ways possible. We are ISO 9001 certified, driven by over 1000 professionals in Technology, Research & Analysis and Marketing shared services.
We are proud to be an equal opportunity employer. All applicants will be considered for employment on the basis of merit alone, without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status
ADIS Insight is a database for drug research and development, disease treatment and decision making, based on trusted, scientifically sound data. The accurate and robust data is drawn from medical conferences, leading scientific publications, government agencies, and company information. It is then expertly reviewed, assessed and summarized by a team of scientists resulting in a single search on the database that delivers results on drugs, trials, deals and safety.
The Drugs database provide leading, evidence-based scientific and market information on drugs in commercial development worldwide. Drug and cell-based products are tracked across all therapeutic areas and throughout the entire development process, from discovery to launch. This vital competitive information is used by our customers/stakeholders (Pharmaceutical industry, CROs, Academic institutes, Financial organizations) to take better business decisions.
Job Type: Permanent
Job Location: Tower 9, Magarpatta City, Pune – India (Working in Hybrid Model)
Years of Experience: 3+ years
Educational Qualifications: B. Pharm, M. Pharm, B. Tech/ M. Tech.(Lifesciences), M.Sc./B.Sc. (Life science), BDS, BHMS, BAMS, Ph.D. (Pharma/ Life science)
Eligibility: At least 24 months of experience in the current (Scientific and Medical Writing) role
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
Key Responsibilities:
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
Day at 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
At Springer Nature, we value the diversity of our teams and work to build an inclusive culture, where people are treated fairly and can bring their differences to work and thrive. We empower our colleagues and value their diverse perspectives as we strive to attract, nurture and develop the very best talent.
Springer Nature was awarded Diversity Team of the Year at the 2022 British Diversity Awards. Find out more about our DEI work here.
If you have any access needs related to disability, neurodivergence or a chronic condition, please contact us so we can make all necessary accommodation.
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