Arif Ali Channa
Pharmacist
Berlin
Summary
I'm Pharmacist and overall 14 years of experience in Quality Assurance & About 08 years of managerial experience. I'm seeking mid-level position within operations, which could further allocate professional and organizational growth. I can demonstrate myself as a role model in technical support function especially Change Management, Deviation Management, Floor Management, Internal Audit / Self inspection & CAPA, OOS Investigation, recall management, Validation & Qualification, vendor qualification & approval, In process & Line Clearance, batch documents preparation revision & issuance, ISO 9001:2015, Quality Management System, ISO 13485 Medical Device, ISO IEC/17025 Lab accreditation. Also I have experience of Pakistan & outside Pakistan (Bahrain) and handle many regulators in audit such as DRAP, NHRA, MEHRA, WHO & PIC/s.
Overview
11
11
years of professional experience
6
6
years of post-secondary education
3
3
Certifications
2
2
Languages
Work History
Head Quality Assurance
Sanofi Pakistan
2 2023 - 4 2024
- Develop, implement, manage, audit, and maintain GMP quality systems
- Coordinate and perform all vendor qualification and compliance audits
- Develop, manage and maintain a GMP compliant document control system
- Oversee investigations of all non-conformances (deviations, errors etc.)
- Coordinate and perform CMO audits and responsible to prepare report and close all observations and make sure quality agreement is prepared and updated
- Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company
- Work across all disciplines (e.g
- Manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies
- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes
- Lead, manage and ensure proper training to any relevant change management programs throughout the company
- Provide quality guidance to product development projects and programs
- Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost
- Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being many regulatory audit such as DRAP
- Ensuring that there is a self-inspection programme in place which is communicated to Operations to meet the requirements of EU GMP/PICS/TG/MHRA etc
- Lead APQR to all non-sterile products
- Ensure there is no open change control action plans in the department
- Ensure all batch documents are reviewed and released on time
- Coordinate with all departments and responsible to close the CAPA on site.
Manager (Head QMS & GMP)
Martin Dow Marker (Formerly Merck Pvt. Ltd.)
03.2022 - 02.2023
- Manage and maintain an effective Quality Assurance program for the plant in alignment with Global Operating Procedures and capable of maintaining ISO 9001,14001 certification status
- Manages and oversees the daily activities of the Quality Assurance Unit
- Tracks and manages unit performance against site metrics
- Manages Quality Systems to ensure timely closure of Deviations, Investigations, Corrective Actions, etc
- Identifies and implements action plans to mitigate risks and drive continuous improvement
- Reviews and approves Standard Operating Procedures, Master Production Records (if necessary) and Specification Test Records
- Reviews batch production records
- Reviews and approves validation protocols and reports
- Collaborates with various departments and facilitates facility and cGMP training as necessary
- Serves as a Quality contact for clients
- Performs Quality System reviews as required
- Communicates compliance concerns to Director/Departmental Managers
- Proactively works to improve quality systems and enhance overall quality
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements
- Fosters and develops staff through work assignment and establishing of stretch goals, with a focus on individual growth and planning for future needs of the organization
- Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
Manager (HEAD)- Quality Assurance
Pharmatec Pakistan
07.2020 - 03.2022
- Review operating procedure to ensure compliance with all related procedures, instruction & quality manual
- Established procedure and method to comply with applicable GMP, ISO requirements & customer expectations
- Review the data analyzed results & recommendation changes based on findings
- Drive continues quality improvement projects & global harmonization projects
- Understands and applies GMP principles to the manufacturing and oversight of Active Pharmaceutical Ingredients (API) following global regulations
- Works with site management and peers to lead Quality and Compliance
- Release / reject of batches manufactured in GMP area
- Review, evaluation, and approval of change controls / deviations / temporary change / chromatographic errors etc
- Monthly review of change controls /deviations / temporary changes for compliance
- Review and approval of trends for non-conformance
- Conduct self-inspection of various departments as per schedule
- Imparting Training on relevant SOP's to concerned departments
- Compilation of Site Quality Report and presentation of data on monthly basis
- Review of Risk Assessments, Quality Technical Agreements between Teva and various contract laboratories, Intra Company- Quality Technical Agreement (IC-QTA)
- Perform audit of Contract Laboratories, Third party vendor in co-ordination with Subject Matter Expert.
Manager- Quality Assurance
Aspin Pharma (Formerly Janseen USA)
06.2018 - 07.2020
- Acts as the facility Management Representative (MR) with respect to ISO9001:2015
- Maintain compliance to the requirements established in the quality management system
- Evaluate the performance of the quality system and identify areas that need improvement to senior management
- Ensure awareness of customer requirements
- Ensure that the quality policy is communicated and understood within the facility
- Review compliance to training requirements
- Manage / perform QA review of key documentation
- Lead projects and programs to achieve and improve facility targets and objectives
- Report to the management of Sterigenics on the performance of the quality management system and any need for improvement through management review
- Ensure that processes needed for the local quality management system are established, implemented, maintained, and improved
- Implement continual improvement culture
- Facilitate quality improvement tools
- Represent the company in quality matters
- Manage and coordinate the Corporate Internal Audit and Supplier Audit Programs and perform audits as a Lead Auditor as required
- Corporate Quality Agreement coordinator
- Coordinate and implement corrective and preventive actions
- Conduct routine CAPA meetings
- Participate at QA-meetings.
Assistant Manager - Quality Assurance
Bahrain Pharma. (BIIP, Hidd, Bahrain)
02.2014 - 06.2018
- To check the compliance of following; Vendor Certification and Approval, BMR issuance, In-process controls, Deviation control, CAPA Management, Change Control Management, Product Quality Review, Product Complaint Management, Risk Management, Recall System, Validation / Qualification, Self-inspections and Internal audit.
Officer- Compliance
PharmEvo Pharma. (Karachi, Pakistan)
09.2011 - 03.2013
- Responsible to conduct the audit of factory (Production, Quality Control , Engineering, Quality Assurance, Admin, Purchase& Warehouse department)
- Also responsible to conduct External Audit of Vendors (Raw Material and Packing) to verify that Factory and its all associate fulfill the all regulatory requirements (Local, WHO, CFR, FDA).
Education
DOCTOR OF PHARMACY - pharmaceutical Science
BAQAI MEDICAL UNIVERSITY
01.2006 - 04.2011
Master of Science - Supply Chain & Logistics
ARDEN UNIVERSITY
Berlin 04.2024 - 04.2025
Skills
PROFESSIONAL SKILLS
Inprocess Control Management
Annual Product Quality Review
OOS/ OOT
Internal Audit and Self Inspection
Vendor Evaluation
Risk Management
Training Management
Change Control Management
Deviation Management
Market Complaint
Product Recall
Validation & Qualification
Regulatory Related Work
SOFT SKILLS
MS WORD & EXCEL
Team Work
Time Management
Flexibility / Adaptability
Pressure Handling
Certification
Registered Pharmacist- Pharmacy Council of Sindh, 02/18/2022, 7755
Current Location
Berlin, Germany
Projects
Preparing WHO dossier and Annual Product quality review, Detail Annual Product quality review of concern product is prepared where we highlighted GAP and productive CAPA was taken to close GAP. Moreover, documentation such Site Master File, Laboratory Information File, Quality Manual, Policies, SOPs of site, controlling mechanism of logbook was procedure was prepared to improve the overall quality and meet the WHO standards., Martin Dow Marker (Formerly Merck Pvt. Ltd.) Site readiness before technical analysis of WHO, Detail Internal Audit was performed CAPA was Taken successfully, and presentation of budget was prepared and deliver to Senior management, Martin Dow Marker (Formerly Merck Pvt. Ltd.) Implementation of SAP S4 HANA, Certificate for appreciation for implementation of SAP S4 HANA, Martin Dow Marker (Formerly Merck Pvt. Ltd.) Costs reduction projects, Installation of steam in S.S jacket in one of our renowned gel products to reduce process time, installation of containers to create extra spaces in warehouse, creating digital library., Martin Dow Marker (Formerly Merck Pvt. Ltd.) ISO 9001:2015 and ISO 13485:2015 certification, Achieve ISO 9001:2015 for Quality Management System and ISO 13485 Medical Device, Pharmatec Pakistan Standard Format for Batch documentation, Prepare the Standard Format for Batch documentation with respect to international guidelines and revise batch documents (BMR / BPR) of all 250 Products., Pharmatec Pakistan Quality week, Initiate the Quality week to promote the quality culture in organization., Pharmatec Pakistan Benchmark audit, Successfully conduct the 05 days benchmark audit from drug regulatory authority of Pakistan, Pharmatec Pakistan Documentation of Quality Assurance, With help of WHO consultant prepare all documentation of Quality Assurance with respect to WHO guideline such as change control, deviation, internal audit, CAPA, Risk Management, SOP of SOP, Pharmatec Pakistan Engineering and Validation documentation, Help in documentation of engineering (SOP's, IQ, OQ) and Validation (PQ) and perform quality risk assessment in Installation of AHU, decommission & dismantling package unit of Granulation & Syrup area., Aspin Pharma (Formerly Janseen USA) Senegal audit, Successfully qualify Senegal audit, Aspin Pharma (Formerly Janseen USA) ISO 9001:2015 and ISO 14001:2018 certification, Achieve as lead QMS and achieve successfully ISO 9001:2015 and ISO 14001:2018 for first time., Aspin Pharma (Formerly Janseen USA) ISO IEC/ 17025:2015 certification, Work as technical lead and achieve the ISO IEC/ 17025:2015 in Aspin Pharma., Aspin Pharma (Formerly Janseen USA)
Timeline
Master of Science - Supply Chain & Logistics
ARDEN UNIVERSITY
04.2024 - 04.2025
Manager (Head QMS & GMP)
Martin Dow Marker (Formerly Merck Pvt. Ltd.)
03.2022 - 02.2023
Manager (HEAD)- Quality Assurance
Pharmatec Pakistan
07.2020 - 03.2022
Manager- Quality Assurance
Aspin Pharma (Formerly Janseen USA)
06.2018 - 07.2020
Assistant Manager - Quality Assurance
Bahrain Pharma. (BIIP, Hidd, Bahrain)
02.2014 - 06.2018
Officer- Compliance
PharmEvo Pharma. (Karachi, Pakistan)
09.2011 - 03.2013
DOCTOR OF PHARMACY - pharmaceutical Science
BAQAI MEDICAL UNIVERSITY
01.2006 - 04.2011
Head Quality Assurance
Sanofi Pakistan
2 2023 - 4 2024
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