Compliance Manager

Position: Manager Compliance

Reporting to: Sr Manager Compliance & Quality Systems

Division: Established Pharmaceutical Division - Operation

Location: Karachi - Landhi Plant

Job Summary

As a regulatory liaison, serve as the primary point of contact for regulatory agencies at the manufacturing site and for commercial regulatory matters and coordinate and manage regulatory inspections and audits, ensuring timely and effective responses to any findings.

Also responsible for implement regulatory compliance strategies across both manufacturing sites to ensure adherence to local, regional, and global regulations and continuously monitor changes in regulatory requirements and update site policies and procedures accordingly. Ensuring that all product labeling, packaging, and promotional materials comply with regulatory standards is a key responsibility.

Major Responsibilities

• Maintain accurate and up-to-date records of all regulatory compliance activities and respond promptly to queries from regulatory bodies such as DRAP
• Conduct regular regulatory compliance audits and inspections to identify and mitigate risks, and I escalate key regulatory updates that are pertinent to the business
• Collaborate with cross-functional teams to address regulatory issues and implement corrective actions
• Provide training and guidance to site personnel on compliance requirements and best practices
• Responsible for implementing and maintaining the effectiveness of quality systems, supporting the site during regional internal audits, and preparing action plans
• oversee the implementation and maintenance of QA internal audit activities at the sit
• Review Action plans (CAPA) Process of QA internal audits and Regional internal audits and follow up for the closure of approved action plan for QA Internal audits as well as Regional internal audits
• To Lead Site change control process, including Change Implementation, Effectiveness & Closure as per regulations
• Applicable Abbott Policies to be implemented as per timeline and effective by date with the coordination of other departmental coordinators and relevant persons
• Play key role for establishment and maintenance of quality technical agreements for local supplier
• Play key role the creation of local audit schedule, execution, and maintenance within the scope of responsibility
  
  

Education/Knowledge & Experience

• Science Graduate/Master; preferably Pharm D
• 5-6 years’ experience in the same capacity
• Knowledge of QA Internal Audits, Change Control activities & Supplier Management and other compliance activities taking place in Quality Department
• Proficient in MS Office
• Teamwork and problem-solving skills