Quality Assurance Specialist

Overview

Main Tasks

• Responsible for document management such as issuance, storage, retention and destruction of documents and records as per defined procedure.
• To ensure good documentation by all concerned personnel and all the documents are as per current GMP requirements and in-house SOPs.
• Preparation of standard operating procedure and provide training on SOPs.
• Responsible for maintaining audit documents such as regulatory and customer audit report and response.
• To ensure that batch production operations are carried out in accordance with cGMP and procedure mentioned in respective batch record.
• Monitoring of manufacturing/packing activities on routine basis.
• Ensure compliance in Warehouse, Manufacturing and Packing.
• To review the batch records including associated data, logbooks etc and to track monthly batch release activities.
• To review master documents.
• Ensure that cGMP requirements are been followed and monitored in the critical process areas.
• To ensure good documentation by all the concerned and all the documents are as per current GMP requirements and in-house SOPs.
• To participate and ensure satisfactory technology transfer, process validation, cleaning validation and hold time studies.
• To implement CAPA for internal & external audits.
• Responsible to participate in investigations.
• To participate in audits and to provide relevant information, when required.
• To prepare Product quality review.
• To Participate in qualification activities.
• Ensure safe work practices, and usage of recommended PPE during activity.
• Ensure compliance to EHS policy and its requirements.
• Responsible for management of document room including labelling and arrangement of files, storage, issuance, and retrieval on approved request.
• Issuance of batch manufacturing and packaging records to production department as per request.
• Any other responsibilities assigned by department head.

& Skills

• Bachelor s degree in pharmacy
• Working knowledge of Microsoft excel, word, power point etc.
• Relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs
• Experience with health authority inspections and third-party audits
• Understanding of pharmaceutical manufacturing and laboratory work (including familiarity with various analytical techniques) a strong asset
• Decision-making skills.
• Excellent communications skills in English (verbal, written, listening, email writing)
• Technical writing skills
• Problem solving skills
• Understanding of manufacturing processes and/or quality systems elements
• Data analysis skills are required
• Able to work in shifts
• Good communication skills.
• Ability to work as part of a team.