Manager, Quality Control

You will be responsible for managing the activities of the quality control laboratory to ensure timely delivery of materials for use in production and releases of finished products from the laboratory. Your role includes ensuring testing of stability samples within the structure of timelines identified in relevant SOPs, maintaining laboratory activities on par with compliance expectations, and providing top-notch inter- and intra-department customer service. With at least 8 years of experience in a laboratory related to a cGMP/Pharmaceutical environment, including a minimum of 4 years in a Supervisor capacity, you will manage the day-to-day operations of the Quality Control laboratory. This involves setting and communicating priorities based on the production schedule and maintaining knowledge of the potential impact of Quality Control activities on activities in other departments. It is essential to effectively communicate this information to the appropriate personnel in a timely manner. Your responsibilities will also involve managing and enforcing laboratory GMP systems to ensure they are adequate, sustainable, and being followed. You will update Laboratory Procedures (SOPs) and Policies, interpret SOPs/Methods/Specifications, and provide clarity as needed. Additionally, you will manage and perform investigations of out-of-specification laboratory results, ensuring that all investigations proceed logically, orderly, and in a timely manner. You will need to review and sign off on various reports and certificates to ensure compliance with specifications. Specialized knowledge in analytical testing involving spectrophotometric analytical techniques, chromatographic techniques (HPLC/GC), dissolution, disintegration, and moisture determination is required. Understanding and explaining compendial (USP/BP/EP/JP) procedures, identifying and troubleshooting instrument-related and procedure-related problems, and effectively planning and organizing multiple tasks with a high degree of complexity are essential skills for this role. You must be able to work in a cross-functional team setting, either as a leader or a member, with a complete understanding of team goals. Resolving conflicts between employees within and between departments and applying cGMP requirements applicable to pharmaceutical quality control laboratory are key aspects of this position. Proficiency in areas such as Laboratory Data Management, Stability Study Documentation, Analytical Method Validation Documentation, and GMP Compliance is required. A Bachelor's Degree (B.Sc) in Chemistry or related field is required, while a Master's Degree (M.Sc) in Chemistry or related field is preferred. A minimum of 12-15 years of experience in an injectable QC Department is necessary for this role. Internal candidates applying for this job role must have completed a minimum of 2 years in their existing role.,