Compliance Manager- Quality

Biophore; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Biophore in Hyderabad, India seeks a senior Regulatory Affairs & Compliance professional to lead adherence to FDA/OSD, GMP, and related standards. The role involves auditing, policy development, and training to bolster quality systems. You will guide regulatory submissions, ensure cross-functional alignment, and support product registrations, leveraging extensive pharma compliance experience at a strategic level.

Qualifications

• M.Pharma degree from a recognized institution (Any Specialization).
• 12-18 years of experience in pharmaceutical industry with expertise in Audit Compliance, Regulatory Compliance, Quality Assurance & Regulatory Affairs.
• Strong understanding of USFDA regulations and Good Manufacturing Practices (GMPs).
• Excellent communication skills for effective collaboration with stakeholders.

Responsibilities

• Ensure compliance with regulatory requirements, including FDA, OSD regulations, GMP guidelines, and other relevant standards.
• Conduct internal audits to identify areas of non-compliance and implement corrective actions.
• Develop and maintain policies, procedures, and training programs related to compliance management.
• Collaborate with cross-functional teams to ensure effective implementation of quality systems.
• Provide guidance on regulatory affairs matters and support product registration processes.

Skills

Regulatory compliance

Audit compliance

Quality assurance

Regulatory affairs

USFDA knowledge

Communication skills

Education

M.Pharma

Job description

Roles and Responsibilities

• Ensure compliance with regulatory requirements, including FDA, OSD regulations, GMP guidelines, and other relevant standards.
  
• Conduct internal audits to identify areas of non-compliance and implement corrective actions.
  
• Develop and maintain policies, procedures, and training programs related to compliance management.
  
• Collaborate with cross-functional teams to ensure effective implementation of quality systems.
  
• Provide guidance on regulatory affairs matters and support product registration processes.
  

Desired Candidate Profile

• M.Pharma degree from a recognized institution (Any Specialization).
  
• Minimum 12-18 years of experience in pharmaceutical industry with expertise in Audit Compliance, Regulatory Compliance, Quality Assurance & Regulatory Affairs.
  
• Strong understanding of USFDA regulations and Good Manufacturing Practices (GMPs).
  
• Excellent communication skills for effective collaboration with stakeholders.