Senior Manager Compliance
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
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 countrys 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/AIn 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
Required Experience:
Senior Manager
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
