Job Description
Responsible for managing Quality Control staff and directing the day-to-day operation of the QC laboratory in the company. Is responsible for analytical activities associated with raw material and product testing/release, in-process and stability testing, laboratory equipment qualification, oversite of QC site of clinical and commercial GMP operations to ensure products are tested to comply with requirements ensuring safety and quality, analytics to support manufacturing from cleaning validation/verification to environmental monitoring.
This position is responsible for implementing and managing cGMP-compliant practices in the laboratory environment and for deploying functional strategy within the department, providing a framework for effective teamwork, setting objectives, and ensuring the development of QC laboratory personnel.
Principal Accountabilities
• Manages day-to-day operations within the QC group in a fast-paced, dynamic work environment in compliance with current regulations and policies (TMDA, OSHA, etc.)
• Formulates and meets quality control objectives. Sets priorities with Operations and other managers to ensure quality and timelines are met to ensure material and products are tested, reviewed, and approved within the accepted time frames. Interprets data and resolves technical issues.
• Reviews, authors, and edits documents, including deviations, change control requests, SOPs, test methods, and related technical reports necessary for laboratory operations.
• Actively participates with cross-functional teams and shares information, as appropriate, with direct reports. Oversees QC-related compliance activities, including investigation closure of any OOS/OOT/Atypical Results/CAPA events.
• Actively directs/leads/performs investigations and implements corrective and preventative action plans.
• Implements procedures and optimal infrastructure to ensure compliance with all regulatory agencies. Serves as the department representative on regulatory audits.
• Provides accurate and timely delivery of data and supports regulatory filings.
• Performs assessments of current systems, to guide impartments to or development of streamlined GMP systems.
• Champions the continuous improvement process, defining process improvement projects.
• Coaches, mentors, leads and manages employees. Ensures that training and other personal development programs are in place for succession planning and the development of subordinates. Ensures that performance opportunities are managed through the performance management system.
• Provides leadership for supervisors, analysts, and technicians to optimize productivity and quality of work. Provides effective planning for department operations to include required resources and the maintenance and communication of cycle times.
Quality/Regulatory Responsibilities
• Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
• Applies cGMP concepts in association with department-specific responsibilities.
• Ensures all documentation produced complies with cGMP standards.
• Responsible for contributing to audit readiness and participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
• Ensures work complies with all state and federal regulations, including but not limited to GMP, TMDA, Internal audit, etc.
Qualifications
• Required, Bachelor of Chemistry or related field
• Should know in Microbiology
• 3+ years in a laboratory environment, preferably in Pharmaceutical Industry including 2+ years managing a team.
• Extensive technical experience in the analysis of small molecules, demonstrated knowledge of modern analytical techniques (HPLC, KF, FTIR, UV, ) and wet chemistry.
• Expertise and know-how with laboratory equipment to train staff and troubleshoot issues when needed.
• Proven ability to lead coach, and motivate employees, clearly communicate job requirements, and effectively manage performance of staff.
• Proven team player with well-developed interpersonal, organizational, mentoring, and communication skills, including written documentation.
• Interest in learning and applying new techniques.
• Ability to change priorities in response to company demands while continuing to deliver exceptional work quality.
• Well-developed supervisory, and organizational, skills.
Share your CV with us at [email protected] and cc [email protected] by 13th January 2024 C.O.B.
