1. Preparation of APQR planner and APQRs in timely manner (with implementation of new initiative of statistical evaluation of APQR data)
2. Handling entire Vendor Qualification function, handling and archiving all documents related to vendor Qualification (e.g. TSE,BSE, Residual solvent statement, quality agreement, Vendor audit related records, etc.)
3. Scheduling and performing internal audits across all the functions of site and also be a team member as needed and assist for other regulatory agency and compliance audit and inspection including customer audits to support the Quality management at HPL
4. Author, Prepare, Review, Revise and Update Quality department Standard Operating Procedures
5. Provide guidance, assist in review and updating other departmental SOPs of Heritage Pharma Labs.
6. Perform and / or provide adequate oversight for bi-annual review of departmental and other cross functional SOPs and undertake performing GAP analysis from cGMP quality compliance for all written procedure requirement at HPL.
7. Review and approve if required all equipment qualification protocols and/or written procedures and relevant documents such as calibration certificate etc. from cGMP compliance and site quality perspective.
8. Author, prepare, review, revise, update, provide oversight, perform usage decision (UD) in SAP and approve if required other facility, validation and qualification reports and documents and forms from cGMP compliance and site quality perspective which include but not limited to Site Master File, Validation Master File, Master Manufacturing Records, Master Packaging Records, Change controls Quality Agreements, various training modules for HPL site, review executed/processed commercial records such as lot manufacturing and lot packaging records, and different forms such as repair and maintenance forms, CAPA forms etc.
9. Assisting in complaint handling – Logging till closing
10. Investigating and authoring Quality Assurance departmental deviations and non-conformances encountered.
11. Assist or perform various annual trend reports per SOPs and Quality metrics from cGMP compliance and site quality perspective.
12. Involving in to any new Initiative being under taken as a part of enhancement of Quality systems
Specialized Skills and Knowledge:
· Knowledge about 21 CFR Part 210, 211 and other GMP guidelines like Validation, Qualification, Out of Specs, Data Integrity etc.
· Thorough experience of handling quality management system (like Change controls, Deviation, CAPA, OOS, OOT, Customer complaint)
· Hands on experience on working on computers – MSOffice.
List the three (3)most important competencies required:
· Analytical skills.
· Problem identification and solving skills.
· Strong communication and presentation skills.
· 3 – 5 years working experience in QA department of a pharmaceutical company with Minimum Bachelor’s degree in Chemistry or Pharmaceutical science
· While performing the duties of this job, the employee is regularly required to move around the production floor. The employee is regularly required to move around various buildings of Heritage. The employee must occasionally lift and or move up to 25 pounds.
· The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change overtime. Additional duties may be assigned based on business needs
Avet is proud to be an Equal Opportunity Employer.
|Job Category||Quality Assurance|