Senior Manager, Pharma Tech

at  Taro Pharmaceuticals INC Canada

Taro Pharmaceuticals Inc. is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.
Established in 1950, Taro’s world class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our company’s focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.
With support from our parent company, Sun Pharma, one of the world’s largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.
Our reward packages have been designed to meet the needs of our diverse workforce and their families. For additional information visit: www.taro.com.
What we offer:
A safe and clean; GMP regulated work environment
Opportunities for career growth and development
A competitive wage/salary
Employee training and organizational development programs, internal mobility programs, and employee recognition programs

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.

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

• 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.