Quality Assurance Specialist
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Key skills for this role
About the Role
Responsible for document management, ensuring compliance with current GMP, conducting audits, and requiring strong communication and problem-solving skills in the pharmaceutical.
Key Skills for This Role
Full Job Posting
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.
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& Skills
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- 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.
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