EHS, Technology Transfer (Formulations)

EHS

Permanent Responsibilities:

1. Monitoring the work permits and ensuring proper execution.

2. Identification of Unsafe Acts, conditions in the plant on regular basis and follow-up for the compliance of the same.

3. Check the fire and safety appliances as per checklists and carry the servicing of fire and safety

appliances as per requirements.

4. Giving the Safety trainings for Employees and contract workmen as per schedule.

5. Conduct & coordinating for incident/accident investigations and develop corrective & preventative action plans.

6. Reviewing the SOPs and updating the same as per requirements.

7. Hazardous waste collection, segregation, storage, maintain the records and dispose.

8. Co-Ordinate with PETL and send the tankers.

9. Conducting Safety Committee meetings.

10. Conducting Mock Drills & Fire drills as per norms.

JD for TT

Should have experience and knowledge in various dosage forms like Solid dosage forms (IR/ER tablets), Pellets / MUPS (Wuster (DIST), Technology), Dry Powders (PFOS). And topical formulation

Documentation part

1. Review of Tech pack documents & Evaluation of gap analysis.

2. Preparation of Process Optimization Protocols / sampling plan and execution of process optimization batches for new products.

3. Preparation and review of process optimization summary reports.

Practically part the candidate should be capable for following

1. Execution/monitoring of exhibit batches of various formulation technologies (Solids orals dosage forms / MUPS or Pellets / Liquid Orals solutions / Dry Powder (PFOS) for USA /EU/CANADA regulatory filing.

2. Involved and handled Process optimization and Commercial Validation batches of critical manufacturing technology MUPS (Wuster process).

3. Monitoring of commercial validation / new lunch products of solids orals (Tablets / Capsules / Pellets0 Liquid orals / dry powders syrups for USA/EU/CANADA/ROW markets.

4. Execution of the query response batches (MUPS/Pellets wuster technology) in commercial scale (Metoprolol succinate extendedrelease tablets).

5. Execution of scale up of pharmaceutical oral dosage forms.

6. Identification for exhibit batches based on data & observations from optimization batches.

7. Handling of change controlees for new products through QMS software.

8. Risk assessment evaluation report preparation for the new products / alternate vendor development products (Alternate source of API)

9. Responsible to co-ordinate with CFT for smooth execution of batches and monitoring of shop floor activity.