JOB DESCRIPTION:

Position:              Senior Manager Compliance

Reporting to:        Director Quality Assurance

Division:              Established Pharmaceutical Division - Operation

Location:             Karachi -Landhi Plant

Job Summary:

Responsible for the implementation, compliance, and ongoing effectiveness of site Quality Management Systems. Oversees all evaluation and qualification activities related to raw materials, packaging materials, suppliers, and service providers. Leads the internal audit program and manages the site change control program to ensure regulatory compliance and continuous improvement.

Major Responsibilities:

• To plan and organize Internal Audit/Self Inspection, Publish Report and carry out follow up for actions plans till final close out
• To review all CAPAs generated through all inspections carried out on site
• Evaluate New systems as per /WHO/DRAP/cGMP and Integrate a Quality Systems approach that will support business goals, customer satisfaction, and assure acceptable regulatory compliance
• Inspection readiness prior to anticipated Audit / Inspection for local regulatory MOH/DRAP and or any country’s regulations/Audits
• Management of Vendor evaluation program for packaging material, Raw material vendors and Service providers of Landhi plant
• Management of Approved supplier list and governance of Vendor Audit process to ensure compliance with cGMP requirements and organizational needs. Development of Audit schedules, execute the local audits in a timely manner and communicate observations in the form of proper Audit reports
• Responsible for the handling & management the site change control activities at site
• Responsible for implementing and maintaining the execution & effectiveness of the Site change control
• Review the Gap assessment management at site against the AQR LL activity, ER initiation, CAPA Plan preparation, tracking & closure as per guidelines provide by group
• Design, lead, and deliver coordinated quality compliance work plans at Landhi site, which meet or exceed Division, Corporate and Health Authority requirements

Education/Knowledge & Experience:

• Science Graduate/Master; preferably Pharm D
• 8-10 years’ experience in the same capacity 
• Strong knowledge of Quality Systems, EQD & AQR policies, Drugs Act, and DRAP requirements
• Experience in operations and/or quality leadership
• Proven project management, analytical, and decision-making skills
• Strong communication, change management, and negotiation skills
• Proficient in MS Office
• Demonstrated teamwork and problem-solving abilities
• Strong communication skills & Change management Skills
• Demonstrated project management skills and training and certifications Knowledge

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Manufacturing

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, Landhi

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable