Title: Compounding Lead
Job purpose
The compounding Lead Hand co-ordinates and monitors the operation of manufacturing, ensuring the highest possible product quality is maintained, while operating in a safe and efficient manner.
Duties and responsibilities
• Perform all compounding duties and responsibilities (see compounding job description) including verifications
• Ensure compliance with cGMP guidelines and SOPs maintaining a high standard of housekeeping and maintaining the daily compounding schedule
• Review batch records and other product documents as required
• Participate in scheduling work activities with other members of operations and support departments as requested
• Ensure that equipment and facilities are in good condition, submit work orders for corrective action when required
• Ensure that all SOPs applicable/relating to compounding are current and that all staff are trained in their use
• Lead staff in a safe environment making sure that safety procedures are followed at all times
• Develop and or assist with continuous improvement projects/processes (5S, Kaizens)
• Investigate in-process, product and equipment failures and write reports when required
• Perform cycle counts
• Prepare batch documents when required
• Maintain inventory of miscellaneous supplies and parts
• Perform calibration/verification of equipment (RPM, Temperature, Vacuum) when required
• Participate in supervisors’ inter-departmental meetings when required
• Participate and conduct training sessions when required
• Provide coaching and recognition/correction to team members. Document performance of team members in a timely manner
• Treat all members fairly, without special privileges
• Lead by example and operate under ethical standards
Additional responsibility (Only applicable to customer facing roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
Qualifications
• University degree with 1-2 years of technical training experience preferred
• Post-Secondary education in scientific discipline is preferred or a minimum of 5 years’ experience in a pharmaceutical environment
• Must possess the ability to function effectively in a team environment
• Knowledge of pharmaceutical manufacturing processes and equipment
• Excellent written and verbal communication skills, ability to communicate and work effectively in a team-based environment
• Self-motivated with a positive energetic outlook
• Able to train and motivate team members to reach stretch goals in production
• Attentive to detail with excellent organizational ability
• Mathematical, scientific, and mechanical aptitudes
• Excellent problem-solver with the ability to troubleshoot and identify the root cause and make recommendations
• Computer proficiency (MS Word, Excel, PowerPoint) combined with working knowledge of SAP and MES
• Strong understanding of current Good Manufacturing Practices (cGMP) Be able to troubleshoot issues which may include:
o Equipment malfunction
o Inconsistent product quality
o Manpower and equipment “bottlenecks”
o Resolving departmental issues, while maintaining department goals. The lead hand must be resourceful and identify available resources to help or assist in dealing with the issue/problem. Resources may include Compounding Manager, QC, Technical Services, SOPs, APR etc.
Working conditions
• May be contacted through telephone during off regular hours regarding “urgent” or emergency issues
• Exposed to dust, odors from raw materials and products, as well as noise from equipment
• Work overtime, including Saturday, when required
Physical requirements
Shop Floor environment
Direct reports
NA