Senior Manager - Production (OSD)

Sun Pharmaceutical Industries, Inc.; Indiana (PA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Sr. Manager for Production in Oral Solid Dosage. This pivotal role involves overseeing manufacturing and packaging operations, ensuring compliance with quality standards, and leading a team to optimize production processes. You will play a crucial part in maintaining high-quality outputs while managing regulatory requirements and internal audits. If you have a passion for excellence and a commitment to quality in pharmaceuticals, this opportunity allows you to make a significant impact in a dynamic environment focused on innovation and compliance.

Qualifications

• 15+ years of experience in manufacturing and packaging of oral solid formulations.
• Strong knowledge in quality assurance and compliance with cGMP standards.

Responsibilities

• Lead manufacturing and packaging operations ensuring quality and compliance.
• Optimize resources and ensure effective collaboration across departments.

Skills

Leadership

Quality Assurance

Risk Assessment

cGMP Compliance

Process Validation

Training and Development

Education

Graduate in Pharmacy (B. Pharm)

Tools

Manufacturing Equipment

Quality Control Systems

Job description

Job Role: Sr. Manager Production (OSD)

Job Function: Formulations (OSD)

Education: Graduate in Pharmacy (B. Pharm)

Experience: 15 to 18 years

Job Summary:

1. Manufacturing and Packaging operations of Oral Solid Formulation.
2. Documentation operations of General Solid Oral Manufacturing and Packaging Department.
3. Ensure that Investigations, CAPA, Batch Records preparation completion schedule is prepared, tracked, and executed as per plan.
4. Review and production approval of documents like:

• Master Batch manufacturing record and Master Batch Packaging record.
• Risk assessment, process validation protocol, Incident and Investigation report, CAPA Reports.
• Protocols & reports.
• Internal Quality Audit, Regulatory Quality Audit 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 demands.

Ensure that there are appropriate manufacturing and technical processes and procedures in place for production.

Ensure that products are produced and stored according to the appropriate documentation to obtain the required quality. The production records are evaluated and signed by a designated person.

In coordination with Quality head, monitor factors that may affect product Quality compliance of GMP and retention of records.

Approve instructions relating to production operations, including in-process controls, and ensure their strict implementation.

Check the maintenance of the department, premises, and equipment.

Ensure that the appropriate process validations and calibrations of control equipment are performed, recorded, and reports made available.

Ensure that the required initial and continuing training of production personnel for SOP, cGMP, and personal hygiene are carried out and adapted according to need.

Optimize resources like men, materials, and machines in manufacturing and packing area.

Ensure efficient collaboration and co-ordination between relevant departments like Warehouse, Engineering, PPIC, Quality Control, Quality Assurance, procurement, and management.

Support Compliance of internal quality/corporate quality/regulatory audit.

Plan & execute various activities viz. Gap Analysis, enhancement, SOPs, protocols, and reports.

Perform Risk Assessment with respect to investigations, internal/regulatory observation response, market complaints, and system improvements.

Coordinate with FDD, PDD (R&D)/MSTG for execution of trial/exhibit/Process validation batches and troubleshooting.

Procure New Suitable Equipment required for process as per cGMP requirements.

Identify and implement improvements to the production process and yield.

Ensure protection of the product from contamination and monitor quality standards of products.

Delegate authority to deputies with satisfactory qualifications 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 department readiness for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies and internal audit teams.

Participate in Internal Quality Audit.

Ensure market complaints, failures, and deviations are investigated, and corrective and preventive actions are implemented as per set timeline.

Perform 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 and compliance and EHS requirements.