Otsuka Pharmaceutical Hiring for Quality Control

Otsuka Pharmaceutical India Private Limited, a leading manufacturer of IV and parenteral nutrition products, is experiencing significant growth and seeking talented individuals to join our team in Ahmedabad, Gujarat. With over a decade of presence in India and backed by Otsuka’s 100+ year legacy of quality, we offer a dynamic and rewarding work environment. We are currently conducting a walk-in interview for several key positions within our Quality Control department. This is an exceptional opportunity to contribute to a global pharmaceutical leader known for its innovation and commitment to patient care.

Quality Control Positions Available:

We are seeking experienced and highly motivated candidates for the following Quality Control roles at our state-of-the-art manufacturing facility in Ahmedabad:

• Quality Control (IPPT/FP, RM/PM): This role involves a wide range of responsibilities in ensuring the quality of our products, from raw materials to finished goods. Your expertise will be crucial in maintaining our high standards.
• Quality Control (Stability): This position is vital for maintaining the stability and shelf-life of our products. Your responsibilities will include sampling, testing, data analysis, and trend identification, ensuring our products meet the highest quality standards throughout their lifespan.
• Quality Control (Micro): In this role, you will play a critical part in maintaining the sterility and microbiological quality of our products and manufacturing environment. Your expertise in microbiological testing and GMP compliance will be essential in safeguarding product quality and patient safety.

Detailed Job Responsibilities:

Quality Control (IPPT/FP, RM/PM):

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• Perform testing of in-process products and finished products according to established specifications and schedules.
• Investigate Out-of-Specification (OOS) results, conduct thorough root cause analysis, and implement Corrective and Preventive Actions (CAPA).
• Ensure timely calibration and maintenance of laboratory instruments.
• Prepare and manage reagents, standard solutions, and other essential laboratory supplies.
• Maintain accurate records and documentation of all testing procedures and results, adhering to Good Documentation Practices (GDP).
• Implement and manage CAPA processes to prevent recurrence of quality issues.
• Carry out sampling of raw materials, packaging materials, and finished products according to established Standard Operating Procedures (SOPs).
• Test and release raw materials and packaging materials according to approved procedures.
• Prepare working standards according to various pharmacopoeias and internal guidelines.
• Maintain appropriate labeling and storage of released materials.
• Adhere to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Prepare chemical and reagent requisitions for procurement.
• Perform stability sample analysis and interpretation of results.
• Compile data for internal quality audits.

Quality Control (Stability):

• Implement procedural changes as per change control notes.
• Verify the accuracy of sample selection and testing intervals.
• Ensure proper storage of stability samples under controlled temperature and humidity conditions.
• Review and analyze test results; perform trend analysis to identify potential stability issues.
• Coordinate with the procurement department for routine supplies.
• Sign and approve all relevant stability study documentation.
• Select product batches for stability studies.
• Ensure responsibilities are covered in the absence of higher-level personnel.
• File deviations for any non-compliance issues.

Quality Control (Micro):

• Maintain a clean and sterile environment according to GMP guidelines and international standards.
• Sample various water systems (WFI, DRO, SRO, raw water, pure steam) for microbiological testing.
• Perform microbiological analysis, including pH, conductivity, Bacterial Endotoxin Test (BET), bioburden, Total Organic Carbon (TOC), pathogen testing, and other relevant parameters.
• Analyze water samples following system maintenance.
• Observe, record, and manage the disposal of microbiological culture plates and tubes.
• Perform timely microbiological testing of finished products, raw materials, and packaging materials according to SOPs and record results accurately.

Ideal Candidate Profile:

• Experience: Experience in the Parenteral/Injectable pharmaceutical industry is highly preferred.
• Shift Work: Willingness to work in rotational shifts.
• Technical Skills: Excellent understanding of relevant testing methodologies and quality control principles.
• Soft Skills: Proactive, detail-oriented, a strong team player, and possess good communication skills. Ability to train other team members is a plus. Strong decision-making abilities are essential.

Important Notes:

• Walk-in Interview: A walk-in interview will be held on April 26th, 2025, from 9:30 AM to 3:30 PM at Otsuka Pharmaceutical India Pvt. Ltd, 21st Floor, B-Block, Westgate, Nr. YMCA, S.G Highway, Ahmedabad – 380 015.
• Requirements: Candidates should bring their updated CV and a passport-size photograph.
• Experience Level: These positions are for experienced candidates only.
• Gender: Due to the rotational shift requirement, male candidates are preferred for these positions.
• Pharmaceutical Background: Only candidates with previous experience in the pharmaceutical industry will be considered.
• Fresher Applications: Fresher candidates are encouraged to submit their CV via email to Anee.Silas@otsukapharma.in.

Don’t miss this opportunity to join a leading pharmaceutical company! We look forward to meeting you.

Company Website: http://www.otsukapharma.in