Quality Assurance(Lifesciences

6 days ago

Patas Pune Maharashtra, India Steribio Lifesciences Pvt.Ltd Full time

**Development and Implementation of QA Processes**:

- Develop, implement, and continuously improve quality assurance processes for injectible products.
- Ensure that all products meet safety, sterility, and regulatory standards in compliance with EU/PICS guidelines.
- Establish and update quality assurance protocols, SOPs, and guidelines to enhance operational efficiency and ensure product integrity.
- **Team Management**:

- Lead, mentor, and manage the QA team to ensure high performance and alignment with regulatory standards.
- Delegate tasks effectively to ensure the team adheres to project timelines and maintains consistent quality checks throughout the production process.
- Foster a culture of accountability, continuous learning, and development within the QA team.
- **Regulatory Compliance**:

- Ensure compliance with all EU/PICS and other relevant regulations governing the manufacture and distribution of injectibles.
- Stay updated on changes in regulatory standards, and ensure that all internal processes are revised as necessary to remain compliant.
- Prepare for and participate in regulatory audits, ensuring that all documentation and processes are fully compliant with external requirements.
- **Quality Assessments and Inspections**:

- Conduct hands-on assessments, quality checks, and internal audits of injectible products to ensure adherence to quality and safety standards.
- Implement corrective actions and continuous improvement initiatives in response to any quality deviations or audit findings.
- Work closely with production and R&D teams to ensure QA integration from product development through manufacturing.
- **Collaboration with External and Internal Teams**:

- Work collaboratively with internal teams (production, R&D, QC) to ensure quality assurance processes are integrated seamlessly into all stages of product development and manufacturing.
- Coordinate with external stakeholders, such as regulatory bodies and third-party auditors, to ensure all products and processes meet global standards.
- **Regulatory and Market Trends Monitoring**:

- Stay informed about the latest market trends, new regulations, and technological advancements in the injectibles sector.
- Proactively recommend and implement changes to QA processes based on emerging trends and regulatory updates to maintain a competitive edge.

**Qualifications**:

- **Education**:

- M.Sc. in a relevant field or B. Pharmacy / M. Pharmacy from a premium institute.
- **Experience**:

- 6-8 years of experience in quality assurance, specifically for injectibles formulation LVP in the pharmaceutical industry.
- **Skills**:

- Expertise in regulatory guidelines, especially EU/PICS regulations.
- Strong knowledge of current market trends and regulatory compliance in the injectibles formulation LVP sector.

Excellent communication and leadership skills for cross-functional collaboration

Pay: ₹800,000.00 - ₹1,000,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Day shift
- Morning shift
- Rotational shift

Supplemental Pay:

- Yearly bonus

Work Location: In person

Expected Start Date: 15/12/2024

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