Responsible for compliance with Customer Technical/Quality Agreements. And evaluating contract manufacturing and testing services and maintaining current valid Quality Agreements.
Participating in Quality Management Review meetings.
Reviewing of stability data and shelf life of products.
Participating in the assessment of FAT, SAT, URS, DQ, IQ, OQ, PQ related to drug manufacturing equipment.
Planning, organizing, leading, and controlling the plant validation activities.
Investigating product complaints, product recalls, and returned products and ensuring appropriate CAPA is implemented successfully, and results are OK.
Reviewing the Site Master File, Quality Manual, Validation Master Plans, Standard operating procedures, product quality review reports, and master batch records.
Carrying out properly and adequately the specified environmental protection measures, such as waste sorting, and waste disposal at the prescribed location, well implement the measures for saving electricity and water.
Reviewing and recommending various trend reports for purified water and environmental monitoring programs.
Coordinating dossier preparation and submission activities (DAV and MHRA etc.)
Verifying that pest and rodent control measures are followed according to the defined schedule and its effectiveness.
Conducting, and reviewing impact assessments and risk assessments for the equipment/utilities/systems.
Handling customer and regulatory inspections at the site.
Batch documents review, approval of COA, and batch release to the market.
Reviewing of change controls and deviations, impact assessment, approval, implementation verification, and closure.
Maintenance of Retention samples for injectables, hard caps, and dry syrup.
Reviewing and monitoring the Qualification and Validation protocols and Reports, organizing, and ensuring the Quality Assurance monitoring for various plant qualifications and validations (Equipments/Utilities/Processes/Cleaning/Hold time, etc.).
Other jobs relating to QA activities.
Ensuring all Product Quality Review reports are prepared according to the schedule and its review, providing recommendations, and following up for CAPA if any need & approval.
Ensuring the compliance of cGMP through Self Inspection and audits (scheduling, coordinating, conducting, ensuring the corrective actions implementation, and closing the inspections).
Coordinating to establish the Quality Management System, procedures, and policies for successful implementation and driving the system smoothly.
Investigating the Deviations, Laboratory Incidents (Lab Deviation), and Non- Conformances, out of specifications in coordination with other user departments. Reviewing and approving CAPA and following up till implementation and results review.
Ensuring compliance with National and International Regulatory cGMP requirements.
Providing induction, ongoing, and GMP training to the staff.
Following up verification for plant calibration and preventive maintenance schedules and ensuring compliance with the schedule.
Vendor evaluation and conducting vendor audits.
Ensuring cleaning, sanitation, and personnel hygiene policies are implemented in the plant.
Responsible for taking on any other specific work within the department in the event of staff unavailability.
