Mfg. QA Specialist Job

Mfg. QA Specialist is needed to perform the following duties:

• Expertise in project planning and execution up to commercialization of products to be specific, “Liquid & Lyophilized vials, Ampoules, PFS, BFS, Ophthalmic products”.
MQA – Manufacturing Quality Assurance:
• Batch release certification, Verify the cGMP/GDP compliance, avoid the data integrity.
• Handling of deviations & change proposals related to the shop floor issues and relevant CAPAs.
• Approval and compliance of change control, deviation, CAPA, QRM, Impact assessment, qualification & validation documents.
• MFR, MPR, BMR, BPR, and Approval & compliance of quality and operations SOPs, In-process Quality Control records.
• Media fill related documents, APQRs and Trends various NVPC.
• Process Validation protocols and reports.
• Media fills batches summary & reports.
• Exhibits batches, cleaning validation batches.
• Monitoring the execution of preventive maintenance of critical equipment and utilities.
• Handling of software systems like., LIMS, ERP, and QMS & Process Pad for daily transactions related to in-process and batch releases.
• Providing support during the Regulatory Audits and Internal Quality Audits. Involving in the Quality Risk assessments related to the shop floor.
• Providing SOP and GMP training for all New/ Existing employees.
• Participating in the brainstorming sessions and investigations to identify the root causes for the identified nonconformances and Market Complaints related to shop floor.
• Involving in the Quality Risk assessments related to the shop floor.
• Ensuring the implementation of CAPAs triggered through various quality elements and regulatory audits.
• Reviewing the change proposals related to the shop floor (i.e., Manufacturing and Packing activity).
• Preparation of Quality review meeting presentation to provide insight of quality elements in the shop floor.
• Preparation of GAP assessments of practices vs procedures vs current Regulatory requirements.
• Involving in the self-inspections and internal audits to ensure adherence to the laid down procedures.
• Provoking Training from the user end at the shop floor to comply, Procedures vs Practices, Regulatory vs Current practices, and supporting perpetually.
• Preparation of training modules on various topics viz., aseptic practices, environmental monitoring and execution of interventions, etc.
• Providing SOP and GMP training for all New/ Existing employees.
• Identifying the training needs of the personnel on the shop floor and ensuring the completion of training as per the scheduled intervals.
• Maintaining the training records of the employees including the contract employees and consultants.

Bachelors degree isrequired in Pharmaceutical Science or Regulatory Affairs or Pharmaceutics.