QA Executive/Officer/Sr Officer | Gufic | Navsari

Job Description

Roles and Responsibilities

• To prepare, review and implement Standard Operating Procedures of Quality Assurance.
• To ensure day to day QA Controls are at place and make QA empowered for the entire plant.
• To ensure that process need for Quality management system are established, implemented and maintained.
• To ensure that a document control procedure is adopted to approve, review and update all changes to documents within the scope of the Quality Management System.
• Responsible for issuance of Quality Management System related formats and maintain the log accordingly.
• To take necessary follow up related to deviation, change control, incident, material and product destructions, Internal Audit, re-packing activity and corrective & preventive action with respective department.
• Responsible to prepare risk assessment documents.
• To ensure that the performance of the Quality Management System is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness.
• Responsible to maintain the document as per current Good Manufacturing Practices.
• Responsible to intervene and call meeting to resolve QMS and GMP related queries.
• Responsible to provide documents for regulatory affair & handling of regulatory queries.
• Responsible for co-orientation with internal department personnel as well as external parties.
• Responsible for audit preparation, execution and compliance.
• Responsible to handle notification to the management related documents.
• To investigate & review non-conforming events including customer complaints and internal non-conforming events and decide on CAPA & follow through for implementation.
• Responsible to prepare, review and implement Master list of Standard Operating Procedures.
• Review of qualification and validation documents.
• To review and implement Annual Training Plan of GMP/Technical/SOP training and to coordinate with concern department for execution of ATP and maintain training record for same and to trained departmental staff on their respective job.
• Responsible for verification & implementation of Batch Numbering system.
• Responsible for allocation of Equipment identification number and review and follow up for updating of equipment/instrument list.
• Responsible for update/review approved vendor list, vendor qualification planning and documents

Desired Candidate Profile

Qualification: Graduation/Post Graduation

Experience: 2-8 Years