Job Description :
Purpose : The QA Specialist will adhere with the cGMP principles and perform Quality reviews as per approved SOPs. Key responsibilities & Accountability : Collaborates with Manufacturing, Validation and Engineering functions to drive Quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure Product Quality.
Performs a quality review on batch documentation received from manufacturing / packaging sites. Performs a quality review of log books.
Involves in the investigations of site deviations / Market complaints / OOS and ensuring effective root cause analysis and assigning of appropriate CAPAs.
Prepares and reviews of Annual Product Quality Review reports. Participation in Internal and Regulatory audits. Compliance to current Good Manufacturing Practices (cGMP) or Good Distribution Practices (GDP).
Collaborates with functional departments to resolve issues and maintain compliance. Actively participate in continuous improvement initiatives.
Qualifications : - Education Bachelor / Master degree in Science / Pharmacy - Experience : 3-5 years in Pharmaceutical Industry preferably in onsite quality checks Real Time Experience in the companies having GMP approval from USFDA / MHRA / TGA / ANVISA / EU authorities.
Honesty and Integrity Self-confident Technical Competencies : Basic IT skills and knowledge in Microsoft Office (word, excel, etc.
Document (SOPs) and investigation Reports writing in English. Knowledgeable with Pharmaceutical cGMP Guidelines.