Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has global and U.S. headquarters in Parsippany, New Jersey, USA, and international headquarters in Zug, Switzerland.
Actavis is the world’s third-largest generics prescription drug manufacturer. Operating as Actavis Pharma, the Company develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries.
The Company is ranked in the top 3 in 12 global markets, the top 5 in 16 global markets, and in the top 10 in 33 global markets.
In terms of our culture, we are a dynamic global team of passionate, talented and motivated people. Guided by our Mission and Our Winning Way, we Challenge, Connect and Commit to make a difference for our customers, our employees, our communities and our shareholders. We are Actavis.
We are currently seeking a
Manufacturing Documentation Supervisor
located in Corona, CA, reporting to the Associate Director, Manufacturing. In this role, you will oversee
, manage, and direct daily activities of the manufacturing and packaging support team. You will lead and supervise a team of eight non-exempt employees. In addition, you will provide support with non routine projects, data collection and analysis and operational improvement initiatives, and department budgets.
Coordinates daily work assignment prioritization to meet the production and shipping schedules.
Ensures training compliance and documents are processed through the change control process to meet production and CAPA documentation requirements.
Works closely with production supervisors and external support groups to ensure facility and equipment production readiness for product transfers and launches.
Supervises and coordinates Batch Record flow throughout the department to ensure timely review, proper filing, logging and distribution both to and from the floor.
Tracks documentation error frequency and trends information; presents monthly tracking to Department Supervisors.
Collects and analysis metrics of batch record review cycle time, Right the First Time, and production downtime.
Investigates frequent or repeated documentation errors and makes recommendations for revisions to Batch Record and SOP documents as necessary.
Coordinates with Planning, QA (Quality Assurance) Documentation, Manufacturing and Packaging to assure the documents flow works in a timely manner with production schedule.
Performs training of operators on proper documentation and Mfg Data Coordinators on procedures for Batch Record reviews as required.
Maintains department Training Manual files and sends all original training documentation to Training department; works with Training department to improve tracking of all historical operator and supervisor training.
Summarizes product yield information for Finance department as required.
Works on special projects for management tracking, batch record investigations, or to direct documentation information to other departments as needed.
Supports expense budget tracking, monthly forecast and accruals
Skills and Experience Required
- Working knowledge of cGMP, FDA, SOPs, DEA and other regulatory compliance requirements.
- Previous leadership and supervisory experience
- Knowledge of pharmaceutical manufacturing and work flow scheduling
- Experience and knowledge for tracking, trending, and summarizing results.
- Principles of safety, worker’s compensation, OSHA and related principles and practices.
- Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
- Reviewing critical documents with accuracy and consistency.
- Training others on proper review of documents.
- Collecting investigative information from multiple sources, identifies sources and solutions, and defines corrective actions for resolution in report fashion.
- Communicating clearly and concisely, both orally and in writing.
- Assimilating information from multiple sources.
- Establishing and maintaining cooperative working relationships with individuals contacted in the course of work.
- Proficient in MS Word and Excel.
- Handling multiple projects, duties and tasks
Bachelor’s degree from an accredited college or university, and a minimum of three (3) – five (5) years supervisory experience.
Actavis, Inc. values the benefits of diversity. EOE M/F/D/V
Watson Pharmaceuticals - 22 months ago