Supervises and oversees daily operations of Production to ensure cGMPs and SOPs are followed, to maximize production and efficiency, and to increase quality while minimizing raw material waste.
Essential Functions:
Performs regular inspections of the department facilities and equipment to assess and ensure compliance with SOPs, cGMPs and safety requirements. Schedules and issues work orders to maintenance for maintenance and repair of encapsulation and ancillary machines to minimize breakdowns and improve efficiency and productivity. Coordinates and interfaces with Engineering for equipment changes and upgrades.
Monitors production and daily operations to maintain departmental quality standards.
Oversees and ensures operating supply and equipment expenditures meet or exceed expectations.
Supervises trains and develops personnel to ensure good manufacturing practices (cGMPs) are followed and to enhance quality and quantity of work performed.
Assists in development and update of standard operating procedures for current and future processes.
Ensures raw material usage and product yields meet or exceed standards.
Coordinates with department Manager to determine production requirements and coordinates, schedules, and prioritizes work accordingly to increase customer service as well as departmental production and efficiency.
Manage employee relations, interviewing new hires and performance reviews
Provides technical support for staff for equipment and processes (trouble shoots and develops control techniques).Prepares and maintains tooling for production; monitors performance closely making adjustments accordingly; evaluates tooling performance.
Monitors the department to ensure safe practices are being performed and unsafe conditions are corrected.
Performs other related duties as assigned.
Additional Responsibilities:
To abide by the Amneal's current rules and regulations regarding day to day business activities
Education:
High School or GED 7 years of related work experience - Required
Associate Degree 5 years of related work experience - Preferred
Bachelors Degree (BA/BS) 3 years of related work experience - Preferred
Experience:
7 years or more in HS -manufacturing experience including supervisory experience in Softgel; Pharmaceutical & Manufacturing
5 years or more in AD
3 years or more in BS
Skills:
Ability to read, write, and communicate in English at a level to facilitate the understanding terminology of the job. - Advanced
Ability to comprehend and follow written and verbal procedures or instructions - Advanced
Have basic math and mechanical skills - Advanced
Ability to operate forklift and pallet movers. (Preferred) -
Specialized Knowledge:
Provide technical expertise for Solid Dosage formulation such as Tablet and Capsule. Knowledge of standardization of production norms based on FDA & DEA regulations.
Specialized in Osmotic Controlled Release Oral Delivery System (OROS) technology. Knowledge of Pharmaceutical Laser Drilling and Ink Printing Machine for specialized solid oral dosage form.
Requires knowledge of 6 sigma and Lean Principles to reduce cycle time and cost while maintaining or increasing Production Quality standard
Coordinate and interfaces with Engineering for equipment Preventive Maintenance and Validation such as IQ, OQ and PQ.
Responsible for Production Planned deviation, CAPA, Change control. Write and update Standard Operating Procedure (SOP). Investigate customer complain
Manages department audits to ensure all department operations are in compliance with cGMP and related SOPs. Audit Employee training data and Production Batch Record
Required technical knowledge on Liquid Filled Hard Gelatin Capsule manufacturing and Machinery
Provide technical support for Extended Release coated Pellets and Tablets; Capsule filled with Pellets and Tablet.
