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Job Description
Senior Manager, Pharmaceutical Technology
General Summary:
This role manages the overall capacity of the Pharmaceutical Technology group to ensure Day 1 Launches, technical transfers, scale-ups, investigation support and operational efficiency.
Principal Duties and Responsibilities:
- Manage Pharmaceutical Technology resources to ensure Day 1 launches for all markets, Operational Support, Product transfers and Scale-ups.
- Manage all aspect of the product launch activities including cross-functional teams including QA, QC, Engineering, Materials Management, Procurement and Operations.
- Work closely with the Validation group to ensure Day 1 launches, Product transfers and Scale-ups.
- Support the QA Investigations Team with Subject Matter Expert (SME) knowledge around process and material related investigations
- Support the Material Management and Vendor Management teams with SME expertise around raw material and vendor approval
- Lead efficiency projects to improve manufacturing processes in Operations
- Owns Master Formula Development and Maintenance
- Supports QC method development activities by providing small scale and full scale batches
- Work with Regulatory Affairs on FDA information request replies, Health Canada Clarifaxes and Deficiency Letters
- When deemed necessary, performs or facilitates quality investigations.
- Complete all GMP Documentation correctly and in a timely manner
- Complete all training assignments and maintain personal training records
- Participate in and/or lead Non Conformance Investigations
- Complete Corrective and Preventive Actions (CAPA’s)
- Initiate, and follow through with actions required to close Change Controls
- Participate in Internal, Customer and Regulatory Audits.
- Develop and update SOP’s as required.
- Identifies training and compliance gaps
- Educates QC analysts, compounders, filling personnel and pharmaceutical personnel on best testing, sampling and investigation practices
- Other duties as assigned.
Knowledge, Skills and Abilities:
- Advanced knowledge of pharmaceutical operations.
- Good knowledge of test method validation and transfer
- Advanced knowledge of GMP, GLP, FDA, HPFBI.
- Good organizational skills and multi-tasking ability.
- Excellent knowledge of continuous improvement methodologies and approaches
- Excellent written and verbal skills.
- Excellent interpersonal skills.
- Good knowledge of applicable software such as Trackwise, MS Office suite,
Background and Experience:
- Minimum of B.Sc. Chemistry or other associated field.
- 5 years of R&D, Quality Assurance, Quality Control or Manufacturing experience in a pharmaceutical or related industry environment with at least 5 years in a supervisory or leadership role.
- Proven record in handling quality investigations
Problem Solving:
- Handles many complex and difficult decisions with respect to launch priorities, equipment availability and batch scheduling. Many pieces need to come together for a successful Day 1 launch and this role is responsible for the overall outcome.
- Problems associated with dealing with individuals from departments, and working on various functions within and outside Taro Canada.
Working Conditions:
- Generally, fairly pleasant surroundings. Exposure to operational environment including higher than normal noise levels. Minor exposure, if any, to various chemicals used in the testing/sampling of raw materials, components and finished products. Fairly level temperatures, etc.