Director - Plant Operations - Pharma

Rubicon Research is a product development company based in Mumbai, India and is recognized as a world class outsourcing partner in pharmaceutical industry, serving Fortune 500 companies worldwide. We are a fast growing, young organization with significant experience in the field of formulation development and providing a full spectrum of development services from preformulation to registration. We also have our
GMP manufacturing plant ( UK MHRA / USFDA approved) from where we provide commercial supply chain.

Title Director- Plant Operations (Ambernath)

Reporting to- Chief Operating Officer

Functional Reporting- Production, Engineering, Administration, Warehouse, QC

Experience - (Yrs) 15-18

Have faced USFDA in the last 2 years

Education M.Pharm /Ph.D

Primary Job Responsibilities

1. Managing Strategic Business Unit: The plant is a separate Strategic Business Unit within the organization structure. Candidate will need to manage the same from a Profit & Loss perspective.

2. Setting up Policies, Procedures, systems & ensure implementation: Ensure effective implementation & adherence to laid down systems especially in the area of GMP & training

3. Providing leadership & problem solving: Director - Plant Operations should provide guidance to the employees to ensure smooth functioning and 100% compliance. Director - Plant Operations should also ensure that any technical or administrative problem is resolved proactively through effective communication across departments. If required problem to be escalated to management in a timely manner

4. Planning and Maintenance (Process Controls)

- Plan, organize and direct the manufacturing and maintenance operations which ensure the most effective return on assets.

- Initiate plans and processes which minimize manufacturing costs through effective utilization of manpower, equipment, facilities, materials, and capital.

- Assist the Corporate Finance for Budgeting and Product Costing exercises.

5. GMP Status

- Organize, plan and maintain the GMP status of the plant. Responsible for leading audits & compliances with various regulatory authorities such as UKMHRA, USFDA, TGA, ANVISA, MH- FDA etc.

- Responsible for successful audits from pharmaceutical companies and partners

6. Production Planning Schedules

- Work along with the SCM team to assure attainment of business objectives and productions schedules while ensuring product standards that will exceed our customers’ expectations.

- Implement manufacturing strategies and action plans to ensure that the facility supports
Rubicon’s strategic initiatives.

- Manage spending against budget and in relation to changes in production volume.

7. Quality Control

- Responsible for working of Quality Control laboratories in compliance with good laboratory practices, coordination for timely release of raw materials, packaging materials, finished products for efficient operations

8. Human Resource Development

- Establish group and individual accountabilities/KRAs throughout assigned departments for problem solving and cost reduction, both on a permanent and ad-hoc basis, depending on need.

- Resolve attrition issues and close recruitment activities in a time-bound manner

- Improve manpower utilization within existing departments and processes.

- Work to establish best management practices through constructive input and action which should improve employee engagement levels.

- Work closely with HR to see that employee grievances are addressed appropriately and in timely manner. Also ensure manpower planning is budgeted in advance and remains at optimal levels.

- Focus on fact based problem solving.

9. EHS: Review & optimize the EHS policy & procedures. Continually improve safety record by addressing both physical safety issues and employee safety attitudes. Maintain and improve housekeeping in all areas

10. MIS: Monthly presentation of performance of plant which includes financial, technical, HR &
compliance performance

If the opportunity interests you please send your cv at swastika.trivedi@icresset.com or call on 9582849757