QA Specialist (QMS)

Job responsibilities:

• Preparation and revision of QA SOPs and always keep it current.
• Review SOPs and Work instructions of other departments and verify compliance.
• Issuance, retrieval and tracking of QMS documents across the site.
• Tracking and facilitating timely completion of QMS events (e.g. Change control, deviation,OOS, CAPA) and related documentation.
• Update of Site Master File (SMF) with necessary changes as and when required.
• Preparation of documents such as Validation Master Plan and report, annual product review.
• Communicate with external service providers on the qualification of new service provider,technical agreements, audit schedule etc.
• Identify and implement process improvement opportunities, cost improvement, and monitor the effectiveness of the same.
• Preparation of validation related documents (e.g., User Requirement Specification, Design,Installation Operational, Performance Protocol of equipment, utilities & facility).
• Participate in periodic reviews to ensure that business and regulatory requirements are met.

EDUCATION & EXPERIENCE:

• Diploma or Degree in Life science or equivalent.
• Experience in a regulated industry preferred.
• A minimum of 3-5 years’ relevant experience in pharmaceutical manufacturing environment. Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.