Vastu Vihar Biotech Pvt Ltd Hiring for Quality Assurance Officer at Bodh Gaya, Bihar, India

Job Title: Quality Assurance Officer/Executive

Location: Bodhgaya, Bihar (On-Site)

Job Type: Full-Time

Joining Type: Immediate

About Us:

Vastu Vihar Biotech Pvt. Ltd., located in Bodh Gaya, Bihar, is focused on developing a drug based on Ribozyme for diseases such as Asthma, Psoriasis, and Chronic Hepatitis. Our goal is to become a leading contributor to the service of mankind by finding ways to combat deadly diseases. With successful and active results in vivo and in vitro testing, we are forging ahead in the journey towards drug development with Ribozyme as the drug molecule.

Job Description:

The Quality Assurance Officer/Executive is responsible for overseeing the implementation and maintenance of the company’s quality assurance systems. This role ensures compliance with cGMP (current Good Manufacturing Practices), preparation and approval of Standard Operating Procedures (SOPs), specifications, validation protocols, and various quality control measures. The manager will also be responsible for vendor qualification, sampling of in-process materials and finished products, and handling market complaints.

Key Responsibilities:

1. cGMP Implementation:

·      Formulate and maintain systems for the effective implementation of cGMP.

·      Ensure preparation, approval, and implementation of SOPs, specifications, standard test procedures, validation protocols, and reports.

2. Documentation and Record Keeping:

·      Oversee the preparation and approval of Master Batch Manufacturing Records and Batch Packing Records.

·      Manage quality reviews and maintain records of all controlled documents and registers.

3. Vendor Evaluation:

·      Evaluate and qualify vendors for raw materials and packaging materials.

4. Sampling and Monitoring:

·      Manage the sampling of in-process materials and finished products.

·      Monitor in-process checks during manufacturing and packing.

5. Change Control:

·      Review and approve changes in product processes, equipment, and other relevant areas as per the Change Control Program SOP.

6. Batch Release:

·      Review batch manufacturing and packing records to ensure compliance with Master Batch Manufacturing Records.

·      Release batches after ensuring all incidents and deviations are recorded and authorized.

7. Annual Product Quality Review (APQR):

·      Prepare APQR and recommend changes in methods or processes.

8. Market Complaints:

·      Investigate market complaints and maintain thorough investigation records.

9. Training Coordination:

·      Ensure all personnel undergo training as per the requirements in the Training SOP.

10. Stability Studies and Audits:

·      Monitor stability studies and carry out internal quality audits to ensure adherence to written procedures.

11. Sample and Record Management:

·      Manage the collection, storage, and disposal of samples and batch manufacturing records.

12. Deviation Management:

·      Approve and manage the disposition of deviations and incidents.

13. Interdepartmental Coordination:

·      Coordinate with other departments to ensure seamless quality assurance processes.

 Qualifications:

·      Master of Science (M.Sc.) or Master of Pharmacy (M. Pharma) in a relevant field.

·      Minimum 2 years of experience in a quality assurance role within the pharmaceutical or related industry.

Skills and Competencies:

·      In-depth knowledge of cGMP regulations and quality assurance practices.

·      Strong organizational and documentation skills.

·      Excellent analytical and problem-solving abilities.

·      Effective communication and interpersonal skills.

·      Proficiency in using quality management software and tools.

·      Ability to work collaboratively with cross-functional teams.

Personal Attributes:

·      Professional demeanour and a positive attitude.

·      Strong interpersonal skills and ability to build relationships.

·      Curiosity and a passion for scientific research.

·      Ability to manage multiple tasks and projects simultaneously.