Operations Supervisor

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Role Description:

• Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm. 
• This role ensures that all production operations comply with cGMP, safety standards, and production schedules.
• The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.
• Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
• Oversees and coordinates Manufacturing and Packaging operations. 

Responsibilities:

Key Accountabilities:

• Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).
• Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.
• Ensure timely execution of production schedules.
• Monitors manufacturing and packaging processes to ensure schedule is met within standards.
• Review and complete shift documentation, including batch documentation, logbooks, etc.
• Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.
• Assist in determining and implementing CAPA.
• Provide training, guidance, and performance feedback for shift employees.
• Ensure training requirements are met.
• Support employee development and cross-training.
• Executes procedures to complete tasks in a compliant and safe manner.

Continuous Improvement

• Captures and reports metrics; troubleshoots downtime to increase operational efficiency.
• Lead or participate in Continuous Improvement projects.
• Troubleshoots and resolves process issues.

Issues & Deviations

• Performs defect evaluations and initiates production events.
• Identifies, reports, and suggests resolutions for processing related issues. 
• Assists in the investigation of unplanned deviations.

Teamwork and Collaboration

• Provides priorities for the off-shift operations, focusing resources on priority products.
• Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.
• Continuous Training Ensures personnel are current with training requirements.
• Stays current on SOPs and cGMPs.
• Continuous Safety & Compliance Contribute to safety audits.
• Ensures out manufacturing/packaging activities safely, as required, on a daily basis.
• Follows all safety and compliance procedures and participates in required training.
• Adheres to all cGMP compliance/regulatory mandates and quality requirements.
• Participate in safety teams, start-up discussions, incident debriefs, etc.
• Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.
• Misc Other related duties as assigned to meet departmental and Company objectives. 

Requirements:

Qualifications Education & Experience:

• Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.
• Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging. 
• Knowledge Proficiency in a body of information required for the job e.g.
• Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
• Thorough knowledge of cGMP and FDA regulations.
• Thorough knowledge of manufacturing and packaging operations. 

Skills & Abilities:

• Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
• Demonstrated leadership, communication, and decision-making skills.
• Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.
• Ability to analyze metrics and troubleshoot downtime. 
• Effectively interfaces with Quality Assurance to inform of deviations or other line issues.
• Demonstrates the ability to work in collaboration with others as a part of a team.
• Ability to lead in Continuous Improvement projects.
• Possess technical writing skills. 
• Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
• Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.