Hiring For Site QA Lead -

JOB RESPONSIBILITY:

Responsible for Quality assurance function as QA-Head of Injectable plants located at Pipan.

Following are the job responsibilities:

• Responsible for QA function (i.e. in-process, validation, QMS and qualification related activities executed and managed at site.
• Approval of written procedures like SOP, specifications, sampling instructions, test methods, validation protocol/reports, Site Master file, validation Master Plan, Quality Manual and other documents as applicable.
• Responsible to ensure that manufacturing processes and cleaning procedures are validated.
• To approve or reject, starting materials, packaging materials, bulk and finished products.
• To ensure that product is manufactured, tested and released in accordance with the established procedure. Responsible for batch release to market.
• To ensure that the required initial and continuing training of personnel is carried out and adapted according to need.
• Ensuring that a timely and effective communication and escalation of quality issues to the management.
• Participation in management review of process performance, product quality and quality system and advocating continual improvement.
• To ensure IPQA activities such as Dispensing, Manufacturing & Packing Area.
• To ensure the vendor are approved as per Amneal procedure.
• Ensure implementation of effective quality system in line with Regulatory requirement
• Ensure establishment, implementation and adherence to current good manufacturing standards.
• To establish adequate course of action to implement current regulatory requirements.
• Handling of complaint related activities as per procedure including complaint related activities in Caliber software and participate in the investigation of product quality complaint to identify the cause and recommend CAPA wherever applicable.
• Responsible to ensure that product recall is performed if any quality issue investigation reveals that there is direct impact on product identity, strength, quality, and purity of drug product during stability studies sample analysis, control sample analysis, complaint investigation.
• Responsible to ensure that Annual product quality review is performed for each drug product and appropriate actions are taken based on the review recommendations (if any).
• Assist in comprehensive investigation carried out to identify root cause and execution of CAPA for deviation, incident, OOT, OOS and product failure, etc.
• Ensure tracking and timely closing of all CAPA initiative through quality documents and evaluate post effectiveness checks of CAPA.
• Handling of regulatory, customer and internal audit as and when required.
• Responsible for the recruitment and training of the people for Quality assurance, develop quality unit personnel to maintain a high technology level that can support and develop departmental goals. Responsible for personnel performance appraisal, developmental plans and effective communication relations for staff.
• Responsible for creating capital expenditure / revenue budget for quality unit.
• To ensure compliance of combination product requirements.
• Support New Product introductions and technology transfer programs.

Please share CV at

bhuvneshwari.rathore@amneal.com

Subject Line : CV for Quality Head