ODF Executive Validation || Baddi

From 5 to 8 year(s) of experience
₹ 5,00,000 - 8,00,000 P.A.

Job Description

Interested candidates kindly share your updated CV to hr@samridhiplacements.com


Job details as below :

Industry : Pharma

Job Location Baddi

Education : M. Pharma/ B. Pharma

Experience : 5+ Yrs

Mandatory Experience : Minimum 6 Years Experience in Qualification & Validation of Oral Products- Tablets.


Person shall be well versed with Qualification of HVAC, Water System, Compression Machines, Isolators, Blenders, Bulk packing lines, Cleaning Validation, Process Validation.

Person with Experience in Hormone Facility shall be preferred.


Followings will be the responsibilities of the position holder:

  1. Preparation and review of Qualification and Validation documents (URS, DQ, IQ, OQ, PQ etc.) for ODF facility.
  2. Execution of qualification and requalification activates for ODF facility.
  3. Co-Ordination with other departments for streamlining qualification activities for ODF facility.
  4. Preparation of SOP, training modules on validation and execution of training sessions for ODF facility.
  5. Design and conducts process validation activities for ODF facility.
  6. Support the evaluation of change control to establish validation assessments and requirements during process and equipment modification.
  7. To prepare protocol and report for process and cleaning validation in compliance with regulatory.
  8. Design the process sampling plan to meets process validation requirements and statistical process monitoring requirements.
  9. Prepare the assessments to support that validated critical process and operational parameters are within qualified parameters.
  10. To assist investigation activities if any failure.
  11. To check and review the process validation BMR/BPR, other related documents of finished good and preparation of COC (Certificate of conformance) for batch release.
  12. To ensure compliance of validation/qualification activities as per Regulatory requirements.

Education

UG:B.Pharma in Any Specialization

Company Profile

Samridhi

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Contact Company:Samridhi

Salary:

5,00,000 - 8,00,000 P.A.

Functional Area:

Other

Role Category:

Other

Role:

Other

Employment Type:

Full Time, Permanent