Qc Officer

To enhance and implement the Quality assurance system in order to achieve Quality standard.
- To motivate and train the sub-ordinates and colleague to improve quality system and current GMP/GLP/GDP/GEP standards in the plant.
- To remain updated regarding the recent international and regulated guidelines.
- To establish, lay down, implement and approve various systems, SOPs and documentation as per current GMP, safety and regulatory requirements.
- To ensure the plant is in a validated state by ascertaining that the appropriate qualifications and validations are done.
- To monitor document data control in process documents related to Quality control.
- To Handling the Market complaints, OOS (out of specification), OOT (out of trend)., Deviation, Incident, Non-conformance, Product recall, Reprocess, Online rejection, return etc. and to suggest and implement methods to avoid reoccurrence.
- To identify Corrective and Preventive Actions and ensure timely tracking and implementation of the same.
- To arrange for and carry out the self-inspection as a member of self-inspection team.
- To effectively coordinate with engineering, production, quality control, Regulatory Affairs, warehouse, purchase, MA holder and corporate technical team.
- To verify URS, DQ, FAT, IQ, OQ, PQ and Requalification of the Equipment /Instruments of all supporting system/area.
- To ensure that the planned changes/ deviation investigations/ out of specifications/out of trend in quality control or manufacturing are notified in accordance with the well-defined reporting system before product is released.
- To monitor in process testing and release/reject of in process material as well as finish product.
- Responsible for Batch release.
- To monitor environment monitoring in the plant.
- To approve the artworks as per regulatory and marketing requirements.
- Handling of audit and compliance.
- Submit the documents to RA.
- To do technical agreement with outsourced agencies for any kind of outside activities.
- To establish and execute the system and supporting system to prevent contamination and cross contamination.
- To add value to various Quality systems at site so as to improve the level of compliance.
- To audit and approve/reject the contract agencies like outside analysis, calibration, quality supplies.
- To evaluate, review and approve specifications, SPE/STP/RDS & COA sampling instructions, test methods, batch manufacturing records, batch packing records and other Quality control procedures.
- To monitor retention of samples (collection, storage, inspection and destruction).
- To review and approve of the calibration schedule and handle the out of calibration.
- To review & approve, master of any Quality management system related documents.
- To develop and implement quality control processes, procedures, and standards.
- To Conduct regular inspections and audits to ensure adherence to quality specifications.
- To Collaborate with cross-functional teams to establish quality requirements for new products or processes.
- To Team Leadership Manage and lead a team of QC professionals, providing guidance, training, and performance evaluations.
- To Foster a culture of continuous improvement and quality excellence within the QC team.
- To Documentation and Reporting Maintain accurate and detailed records of quality control activities, test results, and corrective actions.
- To Prepare and present regular reports on quality metrics and performance to senior management.
- To Problem Resolution Investigate and resolve customer complaints or product defects, implementing corrective and preventive actions as necessary.
- To Collaborate with other departments to address and rectify quality issues in a timely manner.
- To Regulatory Compliance Stay current with industry regulations and standards to ensure compliance.
- To Interface with regulatory agencies during inspections and audits.
- Process Improvement Identify opportunities for process improvement and efficiency in quality control procedures.

**Job Types**: Full-time, Permanent

Pay: ₹20,000.00 - ₹25,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift

**Experience**:

- total work: 2 years (required)

**Location**:

- Sachin, Surat, Gujarat (required)

Work Location: In person