Ipqa Officer, Injectable

**Job Title: IPQA Officer (Injectable Production)Job Summary**:
The IPQA Officer will be responsible for ensuring the quality of pharmaceutical injectable products during the manufacturing process. This includes monitoring production activities, performing in-process checks, conducting sampling, and verifying that operations adhere to GMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures). The officer will collaborate with the production team to maintain a high standard of product quality and compliance with regulatory requirements.

**Key Responsibilities**:

- **In-Process Quality Monitoring**:

- Monitor the entire injectable production process to ensure compliance with established quality standards.
- Perform in-process checks (e.g., visual inspections, weight checks, and checks for defects).
- Monitor critical production parameters and ensure they align with approved specifications.
- Review and verify the accuracy of batch records, logbooks, and production documentation.
- **Documentation and Recordkeeping**:

- Maintain accurate and timely records of in-process quality checks, including deviations and corrective actions.
- Review and ensure that batch manufacturing records (BMR) and batch packaging records (BPR) are correctly filled out and compliant with internal procedures.
- Document and report any discrepancies or deviations from established procedures and take corrective actions.
- **Deviation Management**:

- Investigate deviations and non-conformances in the production process, providing appropriate corrective and preventive actions (CAPA).
- Ensure that all deviations are documented, analyzed, and reported to management as per GMP guidelines.
- Follow up on the implementation and effectiveness of CAPA.
- **Sampling and Inspection**:

- Ensure that raw materials, in-process samples, and final products are sampled according to the required procedures.
- Perform visual inspection of the injectable products for defects such as particulate matter, leakage, and packaging errors.
- Coordinate with the quality control (QC) team to ensure timely release of raw materials, intermediates, and finished products.
- **Compliance with GMP and Regulatory Standards**:

- Ensure all activities comply with GMP, SOPs, and other regulatory requirements (FDA, EMA, etc.).
- Monitor environmental conditions (e.g., temperature, humidity) to ensure compliance with storage and production specifications.
- Assist in audits and inspections by regulatory bodies or customers and prepare required documentation.
- **Training and Support**:

- Provide training to production staff on quality assurance procedures, GMP practices, and hygiene requirements.
- Promote awareness of quality standards among production teams and ensure adherence to procedures.
- **Collaboration**:

- Work closely with production, QC, and other departments to resolve quality issues promptly.
- Participate in continuous improvement initiatives to enhance product quality and production efficiency.
- **Product Release**:

- Ensure that in-process and finished products meet the required quality standards before release for further processing or dispatch.
- Provide support during the final inspection and release of products, ensuring that batch records are completed and compliant.

**Qualifications**:

- **Educational Background**: A Bachelor's degree in Pharmacy, Chemical Engineering, Life Sciences, or a related field.
- **Experience**: At least 3-4 years of experience in IPQA or quality assurance in a pharmaceutical manufacturing environment, particularly in injectable production.
- **Knowledge**: Strong knowledge of GMP, pharmaceutical regulations, and in-process quality controls.
- **Skills**:

- Good analytical and problem-solving skills.
- Attention to detail and ability to maintain accurate records.
- Good communication and interpersonal skills.
- Ability to work collaboratively in a fast-paced environment.

**Preferred**:

- Experience in injectable product production or sterile manufacturing environments.
- Familiarity with regulatory guidelines such as those from the FDA, EMA, or WHO.

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

Pay: ₹25,000.00 - ₹32,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Food provided
- Health insurance
- Internet reimbursement
- Leave encashment
- Life insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift
- Rotational shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

**Experience**:

- IPQA: 3 years (required)
- IPQA, Injectable: 3 years (required)

Work Location: In person