Executive-Process Validations

Aizant; Hyderabad; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Aizant is seeking a qualified professional for Process Validation (Oral Solid Dosage) to manage validation activities across commercial manufacturing in Hyderabad. The role covers execution, documentation, and lifecycle management of validation processes in compliance with regulatory requirements.

Key duties include coordinating SOP reviews, tech transfers, batch review, and overseeing validation documents such as MFC, PVP, PVR, and DPP. Collaboration with PD, QA, QC and RA is essential.

Qualifications

• 4–6 years of experience in OSD (Tablets, Capsules) manufacturing and validation.
• Experience coordinating with QA, QC, PD, RA for process execution.

Responsibilities

• Coordinate review/approval of SOPs, guidelines and work instructions.
• Supervise transfer of lab-scale batches to commercial batches on the shop floor.
• Review/approve Master Formula Card, Scale-up reports, PVRs and related validation docs.
• Assist technology transfer of products from R&D to production.
• Monitor lab-scale and pilot batches for tech transfer products.
• Document experiments online in LNBs and ensure regulatory compliance.
• Coordinate with PD, WH, QA, QC, AD, EG, RA for process execution and audits.

Skills

Validation

Documentation

Cross-functional coordination

Quality systems

Education

B.Pharm / M.Pharm / MSc (Pharmaceutical Sciences)

Job description

Dear All,

We are looking for a competent professional in Process Validation (Oral Solid Dosage) to handle validation activities across commercial manufacturing. The candidate will be responsible for execution, documentation, and lifecycle management of validation processes in compliance with regulatory requirements.

Key Responsibilities:

• 1. Co-ordinate for Review and approve of departmental SOPs/Guidelines/Operating instructions.
• 2. To supervise transfer of batches from lab scale to commercial batches at the shop floor and to ensure quality system compliance.
• 3. To review and approve of Master Formula Card (MFC), Scale up Report, Sampling plan, Scale up BMR, Process validation protocols (PVP), Process validation reports (PVR), Packing validation protocols, Packing validation reports, Hold time study protocols, Hold time study reports, Dissolution Profile Protocols (DPP), Dissolution Profile Reports and Pilot Bio-Batches Documents.
• 4. To assist in Technology Transfer of products from FR&D to production.
• 5. Monitoring of lab scale batches for tech transfer products.
• 6. Monitoring of Pilot Bio- Batches.
• 7. Documentation of experiments online in LNBs.
• 8. Co-coordinating with Cross functional departments i.e. PD, WH, QA, QC, AD, EG, & RA for process execution.
• 9. Trouble shooting during commercial scale execution.
• 10. To carry out feasibility trials in FR&D if required.
• 11. Compilation of all executed batch process documents and analytical documents and assessing the impact on the commercial scale.
• 12. Co-ordinate to Approve the specifications for raw material, packaging material, in-process, and finished product.
• 13. Co-ordination with purchase/ sourcing department for procurement of materials.
• 14. Co-ordination and participation of internal department audits/ sponsor or client audits.

Required Qualifications:

• Education: B.Pharm / M.Pharm / MSc (Pharmaceutical Sciences)
• Experience: 4-6 Years
• Strong experience in OSD (Tablets, Capsules) manufacturing and validation