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Assistant Quality Assurance Manager
REGROW BIOSCIENCES · Pune, Maharashtra, India
Company Description
Regrow Biosciences is India’s leading biotech company pioneering regenerative medicine technology. Established in 2009, Regrow Biosciences has built platform technology for cell-based products and established Biocell, a premium cord blood stem cell bank. Their mission is to improve human healthcare by delivering innovative regenerative medicine solutions.
As an Assitant Manager Quality Assurance at our Cell Therapy Manufacturing facility, you will play a critical role in ensuring the highest standards of quality, safety, and compliance in the production of cell therapy products. You will be responsible for developing, implementing, and maintaining quality management systems and processes to meet regulatory requirements and internal quality standards. The successful candidate will collaborate with cross-functional teams to drive continuous improvement and maintain a culture of quality excellence.
Key Responsibilities:
Quality Management Systems:
- Develop, implement, and maintain a robust quality management system in accordance with regulatory requirements (e.g., FDA, EMA USFDA).
- Ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP) and Good Documentation Practice (GDP) standards.
Regulatory Compliance:
- Stay current with industry regulations and guidelines related to cell therapy manufacturing.
- Interface with regulatory authorities during inspections and audits.
Process Validation:
- Oversee the validation and cleaning processes to ensure product quality and consistency.
- Equipment DQ, IQ, OQ and PQ as per standards.
Batch Manufacturing Record (BMR) Review:
- Conduct thorough review and approval of batch records to ensure accuracy, completeness, and compliance with established procedures.
Risk Management:
- Implement and maintain risk management programs to identify, assess, and mitigate risks associated with cell therapy manufacturing processes.
Training and Development:
- Develop and deliver training programs for facility personnel on quality procedures, GMP, and relevant regulations.
- Collaborate with suppliers to establish and maintain quality agreements.
- Conduct supplier audits to ensure compliance with quality standards.
CAPA (Corrective and Preventive Action):
- Lead investigations into deviations, non-conformances, and customer complaints, implementing effective CAPA measures to prevent recurrence.
Change Control:
- Manage the change control process, ensuring that changes to processes, equipment, or materials are properly evaluated and documented.
Continuous Improvement:
- Drive a culture of continuous improvement by identifying opportunities for efficiency, quality enhancement, and cost reduction.
Document Control:
- Oversee document control processes, ensuring that all relevant documents are maintained and updated as necessary.
Qualifications:
- A bachelor’s or Postgraduate degree in Pharmacy, or MSC microbiology/Biotechnology/ Life Sciences discipline.
- 3-7 years of experience in quality assurance, preferably in cell therapy or, Monoclonal antibodies, or biosimilars, or vaccine, or parenteral drug manufacturing.
- In-depth knowledge of GMP, GLP, GDP, and relevant regulatory requirements.
- Strong leadership and communication skills.
- A demonstrated ability to manage and resolve complex quality issues.
Preferred Qualifications/Experience:
- Experience with cell therapy manufacturing processes, quality control, and emerging technologies.
- Experience with regulatory submissions and inspections, especially CDSCO or EMA or USFDA.
Other benefits: Accommodation at Lonavala, PF, Gratuity, and transportation facility.
Preferred – biological product handling or parenteral drug handling.
Full-time job
Location – GMP and GLP certified stem cell laboratory
City – Lonavala, Pune
Salary: 4.8 Lakhs to 7.2 Lakhs
Location: Lonavala Facility
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