Pharmonix Biologicals Pvt. Ltd Walk-in Interview 2022 MSC/ B. Pharm/ M. Pharm or Relevant diploma for Regulatory Affairs Executive At Thane, Maharashtra, India On-site . Pharmonix Biologicals Pvt. Ltd Notification full details below.Interested and eligible candidates Apply Online.
- Vacancy details:
- Post Name: Regulatory Affairs Executive
- Qualification: MSC/ B. Pharm/ M. Pharm or Relevant diploma
- Experience:Only Female Candidates Can Apply
Job Description: Pharmonix Biologicals Pvt. Ltd Hiring For Regulatory Affairs Executive !
- Important Details :
- Location: Thane, Maharashtra, India On-site
- Salary:₹ 3,25,000 – 5,00,000 P.A
- Post of date:07/01/2022
- Selection Process: The selection will be on the basis of Interview.
Roles & Responsibilities
- Taking follow ups with principle companies.
- Reviewing the customer format of QA/TA if required.
- Preparing the In-house product specification for our own brand.
- Maintaining log of all the Regulatory documents /other technical documents data/ Queries data in the form of Excel sheet.
- If necessary , Referring to Monograph and comparison with product specification/COA.
- Arranging the meetings between pharmaceutical company & principle companies for the crucial queries discussion/Audit.
- Email Co-ordination with principle company for the customer specific QA/TA/CDA/Change control & follow ups.
- Filling the customer format of supplier questionnaire as applicable.
- Able to differentiate between the API & excipients .
- Excipients Data mapping in Excel sheet .
- Raising regulatory documents(Vendor Qualification) request to our principle companies
Product Specific Documents i.e.,
- Vendor COA
- Vendor specification
- TSE/BSE Statement
- GMO Statement
- Allergen Statement
- Gluten Statement
- Melamine Statement
- Elementary Impurity Statement
- Nitrosamine Statement
- Residual Solvents Statement
- Genotoxic Statement
- Process flowchart
- Latex free Statement
- Aflatoxin Statement
- Bisphenol/Phthalate Statement/Dioxin Statement
- Package configuration
- Label Specimen
- Kosher/Halal Statement
- Stability Data
Vendor Specific Documents i.e.,
- Vendor Std. quality questionnaire
- Manufacturing License
- Quality policy
- Site quality overview/ Plant Layout
- Organization chart
- TBA/TCA declaration
- Debarment Declaration
- Equipment list
- Accreditation Certificates eg., cGMP/ISO/OHSAS/WHO Certificates
- Product List
Pharmonix Biologicals Pvt. Ltd. is committed to cure the ailing humanity through Quality. Established and incorporated in the year 1985,by people/Group having experience of and exposure to pharma trade of more then 40 years.