Manages the laboratory and its entire team for the raw material, in-process, finished product and stability testing. Laboratory testing encompasses assays performed on raw materials and drug product at various stages to determine product safety and quality.
Responsible for activities relating to the daily function of the Quality Control laboratory and strategic planning for the laboratory and laboratory staff.
expert on analytical testing,
heavily involved in partner and regulatory audits, site metrics meetings, site-wide improvement projects, budgeting and data review and interpretation, including protocols, investigations, and laboratory documentation.
operates with very limited supervision and must be able to work both independently and on teams.
Adheres to safety rules and awareness, demonstrates good safety practices at all times. Takes initiative to report and correct safety hazards. Uses Personal Protective Equipment (PPE) associated with assigned tasks.
Demonstrates and promotes the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
Executes against project plans and goals as assigned by Quality Management.
Meets productivity, quality and teamwork metrics .
Performs all assigned tasks according to applicable camps and internal written procedures.
Follows strict good documentation practices per company's SOP and cGMP regulation.
Actively completes assigned training activities and documents training within assigned time frames and before performing any activity associated with the training topic.
Functions as a subject matter expert within the analytical laboratory and provides support at all times.
Monitors laboratory resources, identifies/reports resource gaps, and assists in recruiting, screening, procuring, and/or qualifying needed resources.
Works independently and is able to facilitate non-routine assignments.
Mentors and develops staff to maximize staff performance and objectives.
Works in collaboration with other departments to evaluate and recommend improvements to analytical methods associated with validation, transfer, or review activities.
May manage inter-departmental projects to ensure timely completion of objectives.
Maintains utmost level of confidentiality at all times
Performs instrument/method troubleshooting within analytical method parameters.
Writes, revises, reviews, and implements technical documentation including protocols, reports; reference standard qualification reports; analytical test procedures; and change controls.
May review analytical testing records/logbooks for compliance with cGMPs, compendial requirements, and company procedures/protocols.
Reviews and/or writes technical reports, procedures, investigations and protocols.
Provides problem solving skills to support the resolution and documentation of investigations for laboratory and manufacturing issues
Draws conclusions from data and communicates those conclusions is writing.
Determines root causes of non-conformance and recommends corrective action. Ensures timely closure of investigations.
Documents, develops and applies strategies to ensure achievement of scientific objectives by monitoring/ evaluating the completion of tasks.
Establishes policies, procedures, and practices associated with laboratory activities including safety, testing, scheduling and documentation.
Maintains and improves GMP compliance and documentation.
Schedules laboratory testing and associated activities to minimize operational disruptions to departments.
Performs training and supervises staff in use of instrumentation and testing techniques, protocols, procedures, cGMPs, and regulated safety guidelines.
Performs annual review of data generated by the Quality Control Laboratory. Generates data figures and trends. Presents and evaluates annual results to the Quality Management.
May perform internal audits of Quality Control.
May perform external audits of vendors with respect to laboratory GMP's.
Determine and maintain laboratory budget.
Desired Candidate Profile
Applicant Msut have Master Degree in Pharmacist / Chemist / Microbiologist
with Years of Experience: Min: 5-7 years in Pharmaceutical industry have skill experience in
Broad knowledge of Chemical and industrial Microbiological principles, Full awareness in methods, wet chemistry, chromatographic analysis, analytical methods (i.e., HPLC, GC, UV), and an understanding of separation theories. Environmental monitoring, identifying microorganisms, identifying sampling points, checking signs for contamination, Good written and verbal communication skills; highly organized. PC literate with basic knowledge of MicroSoft office application software.