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A leading company is seeking a Quality Control Lab professional to manage lab operations and ensure timely analyses of various materials. The candidate will prepare SOPs and maintain quality control documentation. Ideal applicants should have a Science degree and experience in Chemistry, along with strong analytical and communication skills.
Job Duties and Responsibilities:
Quality Functions:
• Responsible for the operations of the Quality Control Lab.
• Ensure that all lab analyses (starting materials, packaging materials, intermediates and finished products, stability samples etc.) are done in a timely manner, according to established test method and to provide accurate results.
• Prepare or revise Standard Operating Procedures (SOPs) relevant to product quality.
• Prepare or revise Specifications, Test Methods and Quality Control Procedures for all starting materials, intermediates and finished products.
• Ensure the maintenance of reference and retention samples
• Ensure that on-going stability studies are conducted for finished products as per cGMP requirements
• Perform sampling and testing of Starting Materials (Packaging) in accordance with Standard Operating Procedures (SOPs) in a timely manner.
• Perform Product testing in accordance with Standard Operating Procedures (SOPs) in a timely manner.
• Perform Analytical Method Validation and Cleaning Method Validation
• Assist in validation or revalidation of manufacturing processes
• Handle installation, operation, calibration and maintenance of lab instruments.
• Maintain good lab practice, lab safety, inventories and housekeeping programs.
• Participate in the investigation of product complaint in evaluation of returned goods relating to product quality.
• Perform supplier qualification.
• Conduct and coordinate Out-Of-Specification/Deviations/atypical results investigation.
• Review Changes, Deviations, Corrective and /or Preventive Actions as Area/Process Owner.
• Ensure that the required initial and continued training is carried out to quality control personnel.
• Maintain all Quality Control documents and records.
Requirements:
• Candidate must possess a Degree in a relevant Science field or related discipline
• Lab experience in a Chemistry related field
• Hands-on experience in GC • Must have experience in Analytical Method Validation
• Knowledge of GLP
• Meticulous, Independent, takes initiative and able to multi-task
• Good communication skills.
This position may have to undertake some of the responsibilities of the QA in his/her absence.