Qms Officer, Pharmaceutical

**Job Title**: QMS Officer - Pharmaceutical Injectable Unit

**Job Summary**:
The QMS Officer is responsible for the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) within the pharmaceutical injectable manufacturing unit. The role ensures adherence to regulatory standards (such as GMP, FDA, EMA) and contributes to the manufacturing processes that produce high-quality injectable pharmaceutical products.

**Key Responsibilities**:

- **QMS Development and Implementation**:

- Develop, review, and update quality management policies, procedures, and work instructions specific to the injectable manufacturing processes.
- Ensure that the QMS complies with international standards (e.g., cGMP, ISO 9001, FDA, EMA) and regulatory requirements for injectable pharmaceutical products.
- Implement risk management strategies to identify and mitigate quality risks in the production processes.
- **Quality Control and Compliance**:

- Ensure quality control measures are in place throughout the injectable manufacturing process, including raw material procurement, production, packaging, and distribution.
- Perform audits to monitor compliance with GMP and other regulatory requirements, and report findings to management.
- Assist in handling deviations, non-conformances, CAPAs (Corrective and Preventive Actions), and change controls.
- **Training and Awareness**:

- Conduct training sessions for employees on quality standards, regulatory compliance, and best practices to foster a culture of quality.
- Maintain training records and ensure that all personnel are up to date on the latest quality practices and regulatory requirements.
- **Documentation and Reporting**:

- Ensure that all quality documentation is accurate, up-to-date, and in compliance with regulatory standards.
- Prepare and review batch records, certificates of analysis (CoA), and other critical documentation for injectable products.
- Manage and track the performance of quality metrics and generate reports for senior management regarding QMS effectiveness.
- **Internal and External Audits**:

- Coordinate and support internal and external audits by regulatory bodies or third-party auditors.
- Ensure all audit observations are addressed promptly with corrective actions taken.
- **Product Lifecycle Management**:

- Monitor product quality throughout the entire lifecycle, from development to commercial production.
- Participate in the evaluation and validation of new products or changes to existing products in accordance with the QMS.
- **Continuous Improvement**:

- Implement continuous improvement processes to enhance the overall effectiveness of the QMS.
- Actively participate in initiatives to optimize product quality, reduce waste, and improve operational efficiencies.

**Qualifications**:

- **Education**:

- A Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or a related field is required. A Master’s degree or certifications in Quality Management (e.g., ISO 9001 Lead Auditor, Six Sigma) is a plus.
- **Experience**:

- Minimum 3-4 years of experience working in a quality assurance or quality control role within a pharmaceutical manufacturing environment, preferably in injectable products.
- **Skills**:

- Strong knowledge of regulatory guidelines (GMP, FDA, EMA, etc.) applicable to injectable pharmaceuticals.
- Proficient in quality management tools and software.
- Excellent communication and documentation skills.
- Strong attention to detail and problem-solving abilities.
- Ability to work collaboratively across departments (e.g., production, R&D, regulatory affairs).

**Key Competencies**:

- **Regulatory Knowledge**: Familiarity with pharmaceutical industry standards and regulations related to injectable products.
- **Quality Assurance**: Expertise in handling quality documentation, audits, and compliance management.
- **Analytical Skills**: Strong ability to analyze and resolve quality issues and deviations effectively.
- **Teamwork**: Ability to work cross-functionally with various departments to ensure product quality.
- **Training and Development**: Experience in conducting training on quality practices and regulatory requirements.

**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**:

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

Work Location: In person