Quality Control - Ph....
Quality Control - Pharma Formulation
نُشرت في :
03-03-2024
صاحب العمل نشط
1 وظيفة شاغرة
حالة تأهب وظيفة
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أرسل الوظائف
الراتب الشهري
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عدد الوظائف الشاغرة
1 وظيفة شاغرة
نُشرت في :
03-03-2024
الوصف الوظيفي
رقم الوظيفة : 2588070
Quality Control Pharma Formulation
Required Quality Control Analyst
Location: Ankleshwar Gujarat India
Industry Pharma Formulation
Must have 35 Years of Experience (Must be from Formulation Industry)
Job Description:
As a Quality Control Analyst in pharmaceutical manufacturing you will play a vital role in ensuring the quality purity and safety of raw materials intermediate products and finished pharmaceutical products. Your primary responsibility will be to perform analytical testing and quality assessments according to established procedures and regulatory requirements.
Key Responsibilities:
Analytical Testing: Perform a variety of analytical tests on raw materials inprocess samples and finished products using laboratory equipment such as HPLC GC UVVis spectrophotometer dissolution apparatus and other instruments. Conduct tests to assess chemical composition physical properties and microbiological attributes.
Method Development and Validation: Develop and validate analytical test methods for the analysis of pharmaceutical products in accordance with regulatory guidelines and industry standards. Optimize methods for accuracy precision sensitivity and specificity and ensure compliance with validation requirements.
Sample Preparation: Prepare samples for analysis by following established procedures for sample collection extraction dilution and filtration. Ensure proper handling and storage of samples to prevent contamination degradation or loss of integrity.
Data Analysis and Interpretation: Analyze test results and interpret data to assess product quality compliance with specifications and adherence to regulatory requirements. Identify deviations outofspecification (OOS) results and trends and communicate findings to relevant stakeholders.
Instrument Calibration and Maintenance: Perform routine calibration maintenance and troubleshooting of laboratory equipment to ensure accuracy reliability and compliance with regulatory requirements. Document instrument performance and maintenance activities according to established procedures.
Documentation and Recordkeeping: Maintain accurate and uptodate records of analytical testing activities including test results laboratory notebooks instrument logbooks and electronic data records. Ensure that all documentation is complete legible and traceable for review and audit purposes.
Compliance Oversight: Ensure compliance with current Good Manufacturing Practices (cGMP) regulatory guidelines and company policies and procedures. Participate in internal and external audits inspections and quality assessments and implement corrective actions as needed.
Quality Control Review: Review and approve analytical test data laboratory reports and quality control records generated by other analysts or technicians. Verify the accuracy and completeness of data and documentation before release for further processing or product release.
Continuous Improvement: Identify opportunities for process improvement efficiency gains and cost savings within the quality control laboratory. Participate in quality improvement initiatives root cause investigations and CAPA implementation to enhance overall laboratory performance.
Qualifications:
Bachelor s or Master s degree in Chemistry Pharmaceutical Sciences Analytical Chemistry or related field.
Previous experience in a pharmaceutical quality control laboratory preferably in a cGMPregulated environment.
Proficiency in analytical techniques and instrumentation including HPLC GC UVVis spectrophotometry and dissolution testing.
Strong understanding of cGMP regulations regulatory guidelines (e.g. FDA ICH) and quality management systems.
Excellent attention to detail organization and time management skills.
Strong problemsolving and troubleshooting abilities.
Effective communication and interpersonal skills with the ability to work collaboratively in a team environment.
Proficiency in MS Office applications and laboratory information management systems (LIMS).
quality control,compliance,formulation,testing,documentation,regulatory guidelines,maintenance
نوع التوظيف
دوام كامل
المهارات المطلوبة
- الكمبيوتر
- التدقيق التقني
- كاد-كام
- ABAP
- التصميم الخارجي
- عمليات الموارد البشرية
الإبلاغ عن هذه الوظيفة
إخلاء المسؤولية: د.جوب هو مجرد منصة تربط بين الباحثين عن عمل وأصحاب العمل. ننصح المتقدمين بإجراء بحث مستقل خاص بهم في أوراق اعتماد صاحب العمل المحتمل.
نحن نحرص على ألا يتم طلب أي مدفوعات مالية من قبل عملائنا، وبالتالي فإننا ننصح بعدم مشاركة أي معلومات شخصية أو متعلقة بالحسابات المصرفية مع أي طرف ثالث. إذا كنت تشك في وقوع أي احتيال أو سوء تصرف، فيرجى التواصل معنا من خلال تعبئة النموذج الموجود على الصفحة اتصل بنا
