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Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Job Description

·        Plans shift activities and assigns shift targets to all shift members to ensure the highest level of production safety, quality, efficiency, output, labour efficiencies, housekeeping, and adherence to production schedule.

·        Manages and monitors the batch processing operations according to Standard Operating Procedures (SOP’s) through various units of operations (i.e., charging liquids/solids, distillation, filtrations, sampling, cleaning, etc.)

·        Facilitates and maintains emphasis on “Safety First” culture by promoting adherence to Environment, Health, and Safety (EHS) procedures and legislative requirements to production team.

·        Ensures that all safety incidents or near misses are reported in a timely manner, root cause analysis performed, corrective and preventive measures assigned and executed as per agreed timelines.

·        Leads Daily Site meetings by working with cross-functional teams, strives for weekly/monthly production targets and ensures proper scheduling and execution.

·        Ensures batches are produced safely and efficiently, in compliance with instructions in master batch records, with focus on weekly / monthly production targets, OTIF and customer delivery schedule.

·        Provides leadership to production team through activities such as performance management, mentoring, recruitment, coaching, training, and corrective actions.

·        Ensures that Good Manufacturing Practices (GMPs) are followed by staff through the effective use of Standard Operating Procedures (SOPs). Ensures all personnel receive and complete GMP and skills training as required.

·        Ensures that all executed GMP documentation, including but not limited to batch records, cleaning sheets, logbooks, etc. are completed by following ALCOA principle, thoroughly reviewed and supports “Right First Time” performance objective.

·        Endorses a culture of “24/7 Audit Readiness” and drives positive compliance ratings for regulatory (Health Canada, FDA), customer, corporate and internal audits. Represents the production team during audits and customer visits.

·        Initiates change controls, deviations, planned deviations and conducts investigations related to non-conformances. Ensures CAPA’s are executed as intended and stimulates an environment where problems are proactively identified and addressed, and deviations become improvement opportunities.

·        Maintains all records relevant to production equipment, cleaning, and processes. Ensures production equipment is well maintained and inspected prior to use, and initiates maintenance repairs by issuing Maintenance Workorder and follows up on the timely completion of the maintenance work orders.

·        Manages the shifts time and attendance management system ensuring accuracy of hours, vacation requests and timely approvals for payroll processing.

·        Reviews training documents (onboarding and skill development) for completeness and identifies any gaps in training assessments and closes the identified gaps.

·        Envisions team’s learning objectives, future competencies, training needs and facilitates the execution of training plans by motivating and sharing feedback.  

·        Monitors process performance, identifies gaps and takes lead on reviewing the master batch records and training of the involved personnel.

·        Owns and reports the departmental KPI’s (safety, quality, productivity, efficiency, labour utilization, downtime, schedule adherence) with Senior Leadership team.

·        Participates in inter-departmental / cross- functional meetings with various key stakeholders and contributes to the implementation and success of continuous improvement initiatives and/or client driven projects.

·        Leads Continuous Improvement / OE projects to support employee development, process improvements, increase equipment uptime, optimization of cleaning practices, production efficiencies and yield improvements using methodologies such as LEAN manufacturing and Six Sigma.

·        Actively contributes to all cost saving initiatives in production department, by focusing on industry best practices and adherence to departmental objectives.

·        Perform other duties as assigned