Summary
Date Posted: Friday, November 29 2024, Base Salary: Not Disclosed

JOB DETAILS:
Summary:
DEI BioPharma Ltd., a Drugs and Vaccines Manufacturing Plant is seeking eligible and qualified applicants for the position of Head Quality & Compliance.
The Head of Quality & Compliance ensures regulatory adherence, maintains product quality, oversees audits and inspections, develops compliance policies, manages risk, leads quality control teams, and ensures continuous process improvement.
The work schedule for this position is: Full Time, 40 hours (5days) per week.
Start date: Candidate must begin working within a reasonable period.

Role and Responsibilities
• Responsible for the entire plant Quality Compliance related to Production, Warehouse, Engineering, F&D, Quality Assurance, Quality control, Regulatory Affairs, Pharmacovigilance & work related to Regulatory authorities.
• Compliance of 21 CFR Part 210 and 211, Development of Quality Assurance system complying with regulatory guidelines; build up an efficient team to establish and implement the Quality Management System; To clear customer and regulatory audits, preparation of compliance reports.
• Ensure the adherence of Good Manufacturing Practices (cGMP) & compliance of ISO standards.
• Chair the GMP committee. Ensure compliance with multiple aspects of GXP.
• Do the selection and Qualification of Vendors, Suppliers, Equipment, and Services.
• Coordinate interdepartmental activity with quality assurance, production, inventory control, supply chain management, purchasing, workshop etc.
• Maintain up-to-date understanding of industry trends and technical developments.
• Ensure compliance with safety regulations and standard operating procedures, providing resources and training.
• Expert in QMS documents like Site Master file (SMF), Pharmacovigilance Master file (PSMF), Validation Master Plan (VMP), Quality Policy, Batch Manufacturing Records and Checklists, Logbooks, Drug Master File(API), Device Master File, Standard Operating Procedures (SOP), Annual Product Quality Review (APQR) & Specification and Standard Testing Procedure for Raw /Packing Material & Finish Products
• Expert in Validation/ Qualification (URS/FAT/SAT/DQ, IQ, OQ, PQ) for instruments & equipment and Process validation, packing validation, Technology transfer, Cleaning validation, Hold Time study, and Area Qualification.
• Making sure that all Deviations, Incidents are investigated and resolved before the release of the batch, improved harmonized and facilitated completion of investigation and deviation using Cause & Effect Diagram, 5Why’s Analysis, Fishbone analysis (Ishikawa Diagram) and other problem-solving tools
• Providing insight to ensure CAPA is prioritized using a risk-based approach. CAPA is effective in ensuring the root cause and contributing factors of the problem are addressed on time.
• Compliance with quality systems e.g. Change Controls, Deviations, Incidences, Customer/ Market Complaints, Non-Compliance, OOS and OOT, CAPA-related activities. Document control and maintenance
• Make sure that stability data updated to support retest or expiry dates
• Ensure compliance with public health regulatory requirements in the factory.
• Ensure disposal of waste as per the regulatory guidelines.
• Handel any situation which would present hazards and which would be difficult to correct.
• Conduct training workshops to the personnel for different aspects of GMP like Good Documentation Practices, Data Integrity (ALCOA), cGMP, GLP, risk assessment, and evaluating the skills.
• Tracking and trending of Key quality indicators for management review meeting and Annual employee meeting
• Talent acquisition & management, team leadership, strategic planning.
• Participate in daily and weekly inter-departmental meeting to ensure better communication from QA, QC, PV, Production, WH, Engineering and Management, smoother workflow and prevention of any delay from QA/QC/RA.
• Lead Auditor in all Self/Internal & Compliance Audits, Vendor and Supplier Qualification, and Lead Auditee in all regulatory audits, third party audits, customer audits
• Support the Development of comprehensive FMEA & Control Plan documents to support of Quality standards.
• To ensure Liasioning, maintenance of required documents, and compliance of statutory requirements under various regulatory bodies
• Continually involve operational efficiency and assess opportunities to reduce cost, taking aggressive action to drive financial performance.
• Create and drive a culture of learning, innovation, mentoring, coaching, succession planning, reward, recognition, respect, and professionalism
• Develop strategic plans to promote and develop talent in the organization to ensure successful knowledge transfer and succession planning.
• Develop performance and efficiency metrics, identifying areas for improvement.
• Involve with the Business Development team for Dossier approval, technical compliance, Site approval, and Product Approval.
• Develop and execute short-term & long-term strategies and objectives for quality function, refined and realigned based on priorities, Initiate & support new/expansion/ continuous improvement projects Planning and Review related activities

EDUCATION:
B. Pharmacy, Specialization in Regulatory Affairs/ PV Yellow belt holder in Quest of Excellence. Versed with ISO 9001, 13485, 22716, 18001, 45001

Experience: 18 – 20 years in Pharmaceuticals (OSD, Beta lactam, Liquid, Semisolids); Health care; Medical Devices; Cosmeceuticals and Aerosols.
Skilled in developing policies, SOPs, and work instructions to ensure consistent quality across all processes.

Skills:
• Comprehensive understanding of industry regulations, including GMP, GLP, GCP, ISO standards, and local/international regulatory requirements (e.g., FDA, EMA, WHO).
• Skilled in developing policies, SOPs, and work instructions to ensure consistent quality across all processes.
• Strong analytical skills to assess quality risks, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
• Experience conducting internal audits and preparing for external regulatory inspections.
• Proven leadership skills to manage, motivate, and develop a quality and compliance team, fostering a culture of continuous improvement.
• Demonstrated ability to make sound decisions under pressure, balancing quality requirements with operational efficiency.
• High ethical standards and integrity in enforcing compliance without compromise.



Job Experience: No Requirements

Work Hours: 8

Experience in Months:

Level of Education: Bachelor Degree

Job application procedure

Interested and qualified, Click here to apply.


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