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