Compliance Manager-Production

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

Job summary

Biophore Hyderabad is seeking a senior compliance professional with a M.Pharma and 12-18 years in the pharmaceutical industry. The role emphasizes audit and regulatory compliance, quality assurance, and regulatory affairs.

You will lead internal audits, develop policies, and guide product registration efforts while collaborating with cross-functional teams in a regulated environment. The ideal candidate will have deep understanding of USFDA regulations and GMPs, and possess excellent

Qualifications

• M.Pharma degree or equivalent from a recognized institution.
• 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 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 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

Audit Compliance

Regulatory Compliance

Quality Assurance

Regulatory Affairs

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.