Sr. Manager, Quality Control (QCC - Injectable)

Description

Experience

• 8 years or more in Laboratory related with progressive increase of responsibilities in cGMP/Pharmaceutical environment, including 4 yrs in a Supervisor capacity.
  

Essential Functions

• Manage the day-to-day operations of the Quality Control laboratory including setting and communicating priorities based on the production schedule. Maintain knowledge of the potential impact of Quality Control activities on activities in other departments and effectively communicate this information to the appropriate personnel in a timely manner.
• Manage/Enforce laboratory GMP systems and ensure that they are adequate, sustainable and are being followed.
• Update Laboratory Procedures (SOPs) and Policies. Interpret SOPs/Methods/Specifications and provide clarity as needed
• Manage and perform investigation of out-of-specification laboratory results ensuring that all investigations proceed in a logical, orderly and timely manner and that appropriate corrective and preventive actions are identified when necessary, review and approve investigation reports.
• Review and signoff process validation/cleaning validation protocols/reports, method verification/validation reports, annual product review reports. Review certificate of analysis to ensure compliance with the specifications.
• Develop and implement systems to improve laboratory GMP compliance and/or productivity.
  

Specialized Knowledge

• Must possess skills in analytical testing involving spectrophotometric analytical techniques, chromatographic techniques (HPLC/GC) employing different data acquisition software, dissolution, dissolution profile and drug release, disintegration, and moisture determination (Karl Fischer, Coulometric, LOD).
• Must be able to understand and explain compendial (USP/BP/EP/JP) procedures.
• Must be able to identify problems during the course of analysis and participate in troubleshooting of instrument-related and procedure-related problems.
• The incumbent must be able to effectively plan and organize multiple tasks with a high degree of complexity in order to complete them in a timely fashion to meet customer needs.
• Must be able to work in a cross-functional team setting, either as a leader or a member, and with complete understanding of team goals.
• Must understand and apply cGMP requirements applicable to pharmaceutical quality control laboratory.
• Must have ability to resolve conflicts between employees both within and between departments.
  

Skills

• Laboratory Data Management - Expert
• Stability Study Documentation - Expert
• Specifications & Test Methods Documentation - Expert
• Analytical Method Validation Documentation - Expert
• CAPA, Deviation, and Change Control Management - Expert
• Training and Compliance Record Management - Expert
• Knowledge of Regulatory guidelines/Requirement - Expert
• Method Validation/verification Protocol Design/ review - Expert
• GMP Compliance - Expert
• Documentation & Data Integrity - Proficient
• People/ Team Handling - Proficient
  

Education

QUALIFICATIONS

• Bachelors Degree (B.Sc) Chemistry or related field - Required
• Master Degree (M.SC) Chemistry or related field - Preferred