- Handling of Change Control, Incident / Deviation and CAPA.
- Following and tracking of Change Control, Incident /Deviation and CAPA.
- Involved in the investigation activity whenever required.
- Responsible for overall QA compliance activity.
1. QRM & MRM:
- Assigning the risk assessment number as per requirement.
- Responsible for reviewing the action plan submitted by all departments and suggesting changes wherever required.
- Responsible for preparing the minutes of meeting the Quality Review Meeting and Management Review Meeting.
- Preparation and review of the risk assessment.
- Preparation of PPT and scheduling Quality Review Meeting and Management Review Meeting.
1. Training and Development:
- Tracking and maintaining the employees training.
- Annual cGMP training for new Employee.
- SOP training evaluation of all departments.
- Maintain Specimen signature records for all employees.
- Imparting the training to cross functional teams like Engineering, production, and other departments on the relevant topics.
1. Document control:
- To prepare controlled copy, uncontrolled copy and other copy as per the requirement and issue to the concern Department / Personnel.
- Monitor the maintenance of the soft copies, hard copies and obsolete copies of all QMS documents.
1. Regulatory compliance:
- Single point of Contact for coordinating with regulatory affairs team and cross functional team to facilitate regulatory compliance requirements.
- Scheduling and tracking regular meetings with RA team to understand the regulatory requirements.
1. Apex documents / SOPs/STPs/Specs:
- Preparation and review of SOPs, logbooks for QA department.
- Review of other departments SOPs for correctness.
- Review of STPs and specifications.
1. Documentation Room:
- Segregation of documents as per displayed room and update the list of documents on a regular basis.
- Management and handling of the documents in the documents room.
- Labeling of the documents/Files/other documents as per requirement.
- Co-ordination with RA for document sharing.
- Perform task and activities assigned by HOD whenever required.
Skills & traits required:
1. Knowledge of various cGMP and Regulatory requirements related to Validation, Qualification and Calibration.
2. Training on QMS functions / Basic SOPs.
3. Training on Validation, Qualification and Calibration SOPs (QA and other departments).
4. Awareness on Process especially related to Engineering operation, utilities and Equipment.
5. Positive Communication skills with cross functional team.
6. Awareness on Software, PLC related to Biotech Equipment’s operations