- Manufacturing and packing of OSD formulation.
- Documentation operations of general solid oral manufacturing and packaging development.
- Ensure Investigations, CAPA, Batch records preparation completion schedule is prepared, tracked and execution of schedule as per plan.
- Review and production of approvals of documents like:-
- A commercial product, stability batches, exhibit batches, characterization batches master batch manufacturing records,s and master batch packaging records.
- Risk assessment, process validation protocol, incidents, and investigation report, CAPA Reports.
- Protocols & Reports.
- Internal Quality audit, Regulatory audit, and related compliance.
- Change control, Standard operating procedure, and other documents including amendments
- Provide leadership and expertise to ensure achievement of production with respect to Quality outputs and commercial demand.
- To ensure that there are appropriate manufacturing and technical processes and procedures in place for that production.
- Ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
- The production records are evaluated and signed by a designated person.
- Coordination with Quality head monitors the factor that may affect product quality compliances with GMP, and retention of records.
- To approve the instructions related to Production operations, including the in-process controls, and to ensure their strict implementations.
- To check the maintenance of the department, premises, and equipment.
- Ensure that the required initial and continuing training of production personnel for SOP, cGMP, and Personal hygiene and carried out and adapted according to need.
- Ensuing Optimization of the resources like Man, Materials & Machine in the Manufacturing & Packing area.
- Ensuring sufficient collaboration and coordination between relevant departments like a warehouse, engineering, PPIC, QC, QA, Procurement, and Management.
- Ensuring coordination with FDD, and PDD (R&D / MSTG) for the execution of trail/exhibit/process validation batches and troubleshooting.
- Responsible for the destruction of rejected products as per SOP.
- Ensuring implementation and adherence to environmental, health, and safety procedures.
- Ensuring Procurement of New Suitable equipment required for process as per cGMP Guideline.
- Identifying and ensuring implementation of improvements to production process / Yield.
- To ensure the protection of the product from contamination and monitor quality standards of products.
- Shall delegate authority to deputies with satisfactory levels of qualification and experience.
- Coach and develop direct and indirect reporters through ongoing, example-based performance feedback, annual performance reviews, and provision of training and development opportunities.
- Assure the all-time readiness department for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies and internal audit teams.
- Shall participate in Internal Quality Audit.
- Responsible for ensuring market complaints, and failure deviations are investigated and corrective and preventive actions are implemented as per timeline.
- Performs all work in support of our corporate values of pride Humility, Integrity, Passion, and with accountability, and diligence. Perform all work in accordance with all established regulatory compliance and EHS requirements.
Desired Candidate Profile:
Experience required – 15 to 20 years in Manufacturing in Pharma Industries.
Industry preferred – Preferably from OSD Site
Qualification required – Graduate in Pharmacy (B. Pharm) / Postgraduate in Pharmacy (M. Pharm)
Location of Job – Halol / Gujarat