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Zenex Animal Health India
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Validation Officer

Validation Officer

Zenex Animal Health India

6 - 8 years

5 - 6 Lacs

baddi

Posted:2 weeks ago| Platform:

Apply

Skills Required

validation activities at herbal ayurvedic nutraceutical facilities validation in pharmaceutical manufacturing validation testing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Develop, review & execute validation protocols and reports for processes, equipment, utilities and computerized systems.
Prepare, review and maintain the validation master plan in line with company & regulatory expectations.
Execute process validation for herbal formulations such as powders, bolus, capsules, gels & liquids.
Perform and review cleaning validation studies, ensuring MACO calculations are scientifically justified for herbal residues.
Conduct QA review & approval of validation lifecycle documents (URS, DQ, FAT, SAT, IQ, OQ, PQ & PV).
Ensure all documentation complies with Good Documentation Practices (GDP) and maintain traceability and integrity.
Maintain complete and organized validation records as per retention and archival procedures.
Ensure adherence to change control, deviation management and CAPA system related to validation.
Conduct risk assessments to identify validation priorities and improvement opportunities.
Participate in revalidation and periodic review of validated systems and processes to ensure continued compliance.
Contribute to the development and implementation of risk-based validation strategies and lifecycle management.
Provide training & guidance to concerned departments on validation procedures and documentation.
Collaborate with Production, Quality Control, R&D & Engineering Department for smooth execution of validation activities.
Participate in internal and external audits, inspections and self inspections providing validation related support and documentation.
Stay current with regulatory updates, guidelines and best practices related to validation and herbal manufacturing.
Understanding of GMP, ISO, WHO-GMP, AYUSH & ICH guidelines.
Familiarity with equipment qualification, cleaning validation, and process validation principles.
Awareness of Herbal Product variability and analytical techniques (e.g. HPLC, HPTLC & UV).

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Zenex Animal Health India

Animal Health / Veterinary Pharmaceuticals

N/A

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Validation Officer

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

Develop, review & execute validation protocols and reports for processes, equipment, utilities and computerized systems.

Prepare, review and maintain the validation master plan in line with company & regulatory expectations.

Execute process validation for herbal formulations such as powders, bolus, capsules, gels & liquids.

Perform and review cleaning validation studies, ensuring MACO calculations are scientifically justified for herbal residues.

Conduct QA review & approval of validation lifecycle documents (URS, DQ, FAT, SAT, IQ, OQ, PQ & PV).

Ensure all documentation complies with Good Documentation Practices (GDP) and maintain traceability and integrity.

Maintain complete and organized validation records as per retention and archival procedures.

Ensure adherence to change control, deviation management and CAPA system related to validation.

Conduct risk assessments to identify validation priorities and improvement opportunities.

Participate in revalidation and periodic review of validated systems and processes to ensure continued compliance.

Contribute to the development and implementation of risk-based validation strategies and lifecycle management.

Provide training & guidance to concerned departments on validation procedures and documentation.

Collaborate with Production, Quality Control, R&D & Engineering Department for smooth execution of validation activities.

Participate in internal and external audits, inspections and self inspections providing validation related support and documentation.

Stay current with regulatory updates, guidelines and best practices related to validation and herbal manufacturing.

Understanding of GMP, ISO, WHO-GMP, AYUSH & ICH guidelines.

Familiarity with equipment qualification, cleaning validation, and process validation principles.

Awareness of Herbal Product variability and analytical techniques (e.g. HPLC, HPTLC & UV).

More Jobs at Zenex Animal Health India