Novartis Released Job Openings On 14-09-2021.Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Eligibility for the QC Specialist y as follows.
Novartis Recruiting Bachelor’s degree with 07+ Years of Experience for QC Specialist Position.Complete Details for the QC Specialist as follows.
Important Details :
- Location :Hyderabad
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 14/09/2021
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- Responsible for metrics in respective area. Provide training in respective area. Supports, initiates, and leads continuous improvement activities for the quality assurance systems on site e.g. document management, change control and training
- Ensures that quality assurance systems e.g. document management, change control system, training, escalation management and risk management are in compliance with local and global requirements
- If leadership role, Efficient department management in accordance with annual plan (budget / activities / timelines) and defined objectives
- Assess validity of clinical/scientific interpretation described in preclinical and clinical documents provided to governmental Health Authorities and identify discrepancies.
- Provide independent clinical/scientific review of clinical summary documents (such as SCE, SCS and CO) and identify content inaccuracies prior to submission to Health Authorities, e.g.: a. Verify accuracy (100% review) of all factual statements within summary document text compared to post-text sources cited. Verify numeric accuracy (100% review) of all data cited throughout text and hand derived in-text tables compared to post-text sources cited.
- Verify appropriateness of all internal/external citations noted within summary document. 3. Develop and provide factual evidence to support all discrepant findings for review and approval by Submission Team or document authors.
- Provide QC review of device specific documents with guidance from senior specialists.
- Compile comprehensive documents containing discrepancies identified among QC reviewers (with corresponding factual ‘Evidence’) for each clinical summary document in preparation for resolution meeting.
- Support the resolution of discrepant findings with Submission Team or author, including verification of implementation, documenting and archiving results. Drive quality forward in the writing process through participation in draft review meetings, providing early identification of potential discrepancies.