Assistant Manager - Quality Control API

Job Summary:

Key Responsibilities:

• Analytical Method Validation:
• Validate and verify analytical methods for both APIs and finished pharmaceutical products to ensure accuracy reliability and compliance with industry standards.
• Stability Protocols Review:
• Review and approve stability protocols to monitor the integrity of API and finished products throughout their shelf life. Ensure all stability studies are conducted in accordance with regulatory requirements and follow up on stability study activities.
• SOP Development and Maintenance:
• Develop implement and maintain Standard Operating Procedures (SOPs) and standard testing procedures for quality control processes ensuring alignment with best practices and regulatory guidelines.
• OutofSpecification (OOS) Investigations:
• Conduct thorough investigations for any OOS results identify root causes implement corrective actions and ensure appropriate documentation of all findings.
• Issuance Control of Hazardous and Poisonous Chemicals:
• Oversee the issuance control and safe handling of hazardous and poisonous chemicals ensuring compliance with safety regulations and providing adequate training to QC personnel.
• Volumetric Solution Standardization:
• Oversee the standardization of volumetric solutions and the management of chemical inventory ensuring compliance with safety and quality protocols.
• Facility Provision and Implementation:
• Ensure all QC personnel have access to adequate facilities and resources implementing improvements in line with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) guidelines.
• CAPEX Requests Preparation:
• Prepare and justify Capital Expenditure (CAPEX) requests for laboratory equipment ensuring that all purchases align with departmental needs and budget constraints.

Qualifications:

• Education:
• Master s degree or PhD in Chemistry Pharmaceutical Sciences or a related field from a recognized institution.
• Experience:
• 812 years of demonstrated experience in Quality Control within the pharmaceutical industry specifically with Active Pharmaceutical Ingredients (API).
• Technical Skills:
• Proficient in various analytical techniques (e.g. HPLC GC UVVis spectroscopy) and knowledgeable about regulatory standards (e.g. ICH FDA EMA).
• Regulatory Knowledge:
• Familiarity with Good Manufacturing Practices (GMP) and Quality Assurance (QA) principles.
• Analytical Thinking:
• Strong analytical and problemsolving skills with a keen attention to detail.
• Leadership:
• Proven ability to lead teams and manage projects effectively ensuring timely completion of quality control objectives.

Application Process:

chemical handling,leadership,active pharmaceutical ingredients,glassware,hplc,oos,capex,high-performance liquid chromatography (hplc),uv-vis spectroscopy,cgmp practices,analytical method validation,out-of-specification investigations,uv,stability protocols review,sop development,api,regulatory knowledge,quality control,capex requests preparation,analytical thinking,facility provision,glps,gc,volumetric solution standardization