Dr. Reddy’s Laboratories Hiring Chemistry & Pharmacy Specialist
Dr. Reddy’s Laboratories announces job opening for chemistry and pharmacy Candidates with degree in chemistry and pharmacy may apply for the job opening at Dr. Reddy’s Laboratories. Pharmacy job opening 2022. Intrested and eligible candidates may check out all the details on the same below:
Job Title: Packaging DHF Specialist
Location: Hyderabad, Telangana, India On-site
Eligbility Criteria & Experience :
- M. Pharma, M.Sc. Chemistry, or BE/B.Tech. Industrial or Mechanical Engineering with 6+ year of experience.
- Hands on experience of 510(k), DHF (Device History Filing), DMR (Device Master Record), DHR (Device History Record) & MDR (Medical Device Reporting), for Regulated Markets including Europe & US.
- Thorough understanding on cGMP Processes (21CFR820), Pharmaceutical Practices, Regulatory Framework, & Quality Processes
Key Responsibilities :
1. Dealing and assessing design concepts of drug delivery systems such as Auto-injector, Pen injector, Prefilled syringe, Nasal, Ophthalmic, Inhalation that are to be considered as Drug-Device Combination Products (DDCP)
2. Prepare Regulatory Submission Package for combination products
3. Responsible for execution of Development Batches, Exhibit/Submission Batches, & take active part in Technology Transfer
4. Implementation of ISO 13485 & creation of Design History File for regulated markets
5. Implementation of ISO
14971 & creation of Risk Management History-DDCP which includes creation of FMEAs and Risk control measures6. Carry out validation requirements and technical acumen including design understanding, part interaction and machine interfaces
7. Conduct Device Functionality Tests as per ISO 11608 & generate Equivalence Reports
8. Response to queries from Drug Authorities
Click Here To Apply Via LinkedIn
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