Quality Control Manager

Unique Biotech  Hyderabad, Telangana, India

Responsibilities :
-Responsible for Quality Control activities related to Raw Material/Packing Materials/Finished Goods
-Should have knowledge on chemical and microbial testing.
-Instrument qualification and lab readiness for OSD Facility
Site compliance with GMP
-Preferable knowledge on probiotics(Lactobacillus, Bifidobacterium, Bacillus sps, cocci sps, yeast )
-Responsible for approving the SOP changes
-Must have Quality control lab troubleshooting knowledge
-Can able to plan prerequisites for audits
-Responsible for carrying out Method Validations, MOAs (Microbial and HPLC)
-Able to handle various customer and regulatory audits NC’S
-Should have desirable knowledge on laboratory equipment (HPLC, SPECTROPHOTOMETER, PH, DT, DISSOLUTION, AUTOCLAVE, LAFU etc)
-Able to handle customer complaints based on product testing issues
-Responsible to carry out accelerated and long term Stability Studies of Products
-Responsible for Environment monitoring and control activities of all work areas
-Should have knowledge on various pharmaceutical guidelines
-Should have experience on environmental monitoring, sterility, microbial limit test, microbial assay and water testing.
-Knowledge on Data integrity
-Should handle microbial deviations, OOS, Change control, CAPA and risk assessments.
-Should have knowledge on QMS system
-Establishment of documents: validation protocol, stability protocol, cleaning validation, analytical method transfer and other related documents
-Preparation and execution of GMP training program and GMP training
-Can able to participate in quality improvement projects
-Annual product reviews and product quality reviews

Requirements :
-Bachelor’s/Master’s degree in Biotechnology/Microbiology
-8-12 years experience as Quality Control (Microbial Testing Preferable)
-Able to handle QC team size of 20-30 members
-Interpersonal and communication skills
-Persuasive ability
-Planning and organizing skills
-Problem-analysis and problem solving skills
-Judgment and decision-making skills

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