Job purpose Duties and responsibilities

Supervise, lead and mentor staff including ongoing coaching, performance feedback and reviews, routine meetings, standard hours, collaboratively identifying objectives and career development
Ensure staff are working in a safe environment and are complying with safety procedures at all times
Responsible for overall day-to-day operation of the lab
Plan, schedule, organize and monitor workload optimally to ensure all operations and tasks are performed within required turnaround time metrics and adherence to set schedules, accommodating testing requirements and meeting departmental goals
Author risk assessments and reports for Nitrosamines, Elemental Analysis and Residual Solvents evaluations
Act as the Lab Manager back up if needed
Investigate and documents discrepancies where required.
Provide troubleshooting of test method and equipment issues.
Responsible for full-cycle internal lab investigations, including trending and preventative actions.
Work closely with and perform follow-ups with Purchasing, Vendor(s), Materials Management, Warehouse, R \& D and the QA Department
Establish and maintain a tracking mechanism to monitor daily requirements
Identify and implement key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements
Create, review and write procedures
Review current systems and procedures and implement changes where appropriate to improve productivity
Provide analytical instrumentation support to the lab staff
Participate in Internal, Customer and Regulatory Audits
Partner with Warehouse and Purchasing to proactively build quality into the processes and systems
Automates job functions to achieve efficiency improvements
Perform monthly Health and Safety Audits and safety awareness training
Respond to Health and Safety audit reports
Other responsibilities and special projects as required
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

Bachelor's Degree in Science or related field
Minimum 5 years' experience in a pharmaceutical manufacturing environment
strong supervisory experience is an asset
Knowledgeable and experienced application of Health Canada and FDA regulations
Ability to establish and maintain trusted and respected relationships with all internal and external stakeholders
High energy level, ability to promote positive change and influence others
Promote and maintain a lean culture
Strong knowledge of analytical instrumentation
Excellent written and oral communication skills with ability to articulate messages and interact with a variety of audiences (internal and external)
Strong organizational, analytical, multi-tasking, detail oriented, trouble shooting, problem solving and root cause identification skills
Proficiency with applicable software (LIMs and Empower)
Ability to identify any deviations to procedures or systems and make recommendations for corrective measures
Ability to implement short range strategies and objectives towards enhancing the quality standards of the department
Any deviations to procedures or systems are brought to the Director's attention with logic, data and corrective measures
Implement short range strategies and objectives towards enhancing the quality standards of the department and facility.

Working conditions

Ability to work under stressful conditions and prioritize workload.
Numerous and varied responsibilities demanding attention and detail.

Physical requirements

Continuous walking and standing
7 x Analyst, QCDs

Sun Pharmaceutical Industries

Sun Pharmaceutical Industries

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Supervisor, Quality Control Development