Documentation and Compliance Supervisor

2 weeks ago

Riyadh, Ar Riyāḑ, Saudi Arabia MS Pharma Injectable Full time
  • Documentation and Compliance Supervisor - Riyadh
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1.1 Manage Quality Assurance and Compliance functions during the production process.

1.2. Ensure implementation of good manufacturing practices and rules during all manufacturing steps.

1.3. Ensure In Process control test and checks are performed during manufacturing.

1.4. Ensuring the validity and effectiveness of the SOP in the In-Process control lab.

1.5. Ensuring that good documentation rules are implemented at every stage of manufacturing.

1.6. Ensure that product quality is maintained by applying GMP rules

Duties and Responsibilities (But not limited to):

  • Follow up and carry out the tasks and objectives required
  • To distribute the work and discuss the priorities and the production plan and the required objectives.
  • Approving all QA/Compliance activities implemented by QA employees.
  • Following up and approval of issued or updated of SOPs, related forms, protocols, batch records, etc.
  • Host regulatory authorities and corporate inspections within MSPS site, as well providing the response.
  • Contact and respond to all regulatory authorities for any requirements
  • Maintain the approval from all authorities by implementing quality culture awareness to ensure readiness for any external inspection.
  • Create, Review, evaluate all documents related to QA and Compliance department (GMP Compliance, Deviation Management, Recall, Complaint management, internal audit ...).
  • Approving and ensure implementation of the training program for QA new employees and continuous training for existing employees.
  • Developing the department functions work plan, assigning work activities, projects, and programs monitoring workflow.
  • Follow-up on new guidelines, Corporate Quality policies and compendial updates, and ensure the update of inhouse systems according to new guidelines.
  • Prepare internal quality audit plan based on risk assessment approach, and perform Quality audits for all quality systems and departments.
  • Review and participate in quality risk management and provide continues support to all departments.
  • Develop, maintain, and update the quality system as per GMP.
  • Follow-up the suppliers and service providers qualification, approval of the qualification and monitor the suppliers and service providers.
  • Generate and/or review of the technical quality agreements.
  • Follow-up on the implementation of CAPAs across departments based on time lines and evaluation of effectiveness of those CAPAs.
  • Review and participate in investigation of deviations, OOS, OOT, customer complaint and recall.
  • Review, approve trends and conclude CAPAs related to trends.
  • Prepare Quality metrics report, monitor Quality metrics and issue CAPAs related to Quality metrics.
  • Prepare of Management review report and follow up on CAPAs raised based on those meetings.
  • Follow-up on the implementation of training system and conduct training of employees based on outcomes of trend analysis.
  • Participate in process improvement projects.
  • Follow-up the closure of customer complaints based on predetermined timeline.
  • Follow-up the closure of Recalls based on predetermined timeline.
  • Issuance and follow up the closure of rapid notification reports on predetermined timeline.
  • Participate in CCR committee where required.
  • Support of the responsible for controlled products to fulfill his duties.
  • Finished products batch release after completion of all requirements and documents
  • Conducting periodic meetings with team members regarding work priorities and ensuring work is progress smooth and inform team of company updates, departmental changes ... etc.
  • People Management: Manage team's personnel affairs (leaves, ), performance management, coaching and training.

Job Requirements:

  • B.Sc. in Pharmacy, Chemical Engineering, Industrial Engineering, or Chemistry Science.
  • At least 5 years of experience in a in pharmaceutical industries, minimum 2 of them in supervisory level at quality department.
  • Proficiency in written, read and spoken Arabic and English.
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