Job Description
Roles and Responsibilities
Functions & Responsibilities
Responsibility of overseeing plant activities to meet business objectives. He /She will be accountable for all aspects of plant performance and will ensure that objectives are attained in a cost-effective manner that is consistent with quality requirements. He or she will also delegate authority to key supervisors in production, manage all functions involved and direct and coordinate operations for the processing plant.
Planning & Implementation
Ensure implementation of GMP, Quality and EMS norms for the plant, initiate actions to address any quality issue, review product compliance as per specifications to ensure compliance to GMP & EMS requirements. Strategizing CAPEX plan for business planning and growth tool for the plant.
Production Scheduling
Analyse and identify resource requirements to meet production objectives, review current material, manpower and machinery status, prepare monthly & weekly production, & packing schedules, monitor & ensure appropriate Engineering & manpower plan to meet customer commitments.
Production
Plan, monitor and manage production and packaging, ensure resource availability, review performance against schedule, monitor progress and modify schedules as pre-required to meet production targets and ensure efficient resource utilization.
Inventory Management
Ensure resource availability, review performance against schedule, monitor progress and modify schedules as required to meet production targets and ensure efficient resource inventory management.
Tech Transfer
Plan the process of smooth tech transfer, follow up with co-ordination teams, ensure trials are undertaken to ensure successful manufacturing of new products from FD/TAG team to production to meet changing customer needs.
Desired Candidate Profile
Candidate Background
- Bachelors Degree in Pharmacy or a masters degree in pharmacy is preferred
- 20+ years FDA approved plant operations experience
- Strong Manufacturing experience in formulations (Soft Gel Capsules) would be preferred.
- Exposure with USFDA is mandatory.
- Excellent communication skills
Leadership traits/ behavioural descriptors
- People management skills
- Problem solving
- Cross functional work ability
- Assertiveness
- Integrity with high level of commitment