Head of Operations
AJA Pharma Industry Kingdom of Saudi Arabia ð¸ð¦
Total des années d'expérience :13 years, 9 Mois
(Production and Supply Chain Management ) at AJA Pharma
Industries- Hail. KSA.
Member of consultant team to build up a new building of AJA Pharmaceutical Industries at Hail with the partnership of
GLATT GERMANY. Build up Sterile, Non- Sterile, Admin, Engineering Buildings, procured the manufacturing filling,
packaging equipment's from various European countries; new large warehouse which have a storing capacity up to 4, 700
pallets at a time with 80 staff at one shift.
Head of Purchasing, Procurement of Raw and Packaging Materials as well as other requirements of Factory. PPIC,
Production Planning of various departments. Logistics and warehouse departments. Member of vendor qualification
auditor’s team. Managing and monitoring daily Operations activities in the departments. Inventory, Production Planning
reports on daily basis. Monitoring the activities in Warehouse. Supervising the logistics department on transportation and
custom clearance issues. Supervising the dispensary for dispensing ingredients, APIs of products for production. The
Production Planner is a key link between Manufacturing Operations
Preparation and implementation Standard Operating procedure (SOPs) as per cGMP. Managing and Supervising to prepare
URS of various machines as required by departments and maintaining them. Interviewing, selecting, and recommending
employees in operations and supply chain Management.
Head of Production ( Sterile & Non- Sterile):
Managing & supervising the pre-production jobs such as washing and dry heat sterilization of ampoules & vials, moist heat
sterilization of sterile area utensils & requirements. 24 Hours 40 staff with 2 shifts system. Personally validated to work and
observe in class 100, 000 sterile plus observing and managing staff operation under class 100 LAF system.
Ensure that operations are performed as per established SOPs and in accordance to cGMP, safety guidelines, policies, other
regulatory requirements and ensuring compliance to laid down specifications of cGMP & Standard Operating Procedures.
Implementing quality plans in co-ordination with production teams; enabling achievement of quality targets, preparing
internal audit schedules. Member of Hygienic and safety committee.
Responsibilities as QA - Compliance Operations Head.
Experience with multinational companies like Janssen-Cilag, Merck, Abbott, Mylan etc.
• Currently holding management position in Compliance heading a 30 staff department. .•In-depth knowledge of all
Quality Systems and Regulatory requirements especially US and European markets. •Managed ERP implementation
and currently responsible for QMS-LIMS implementation.
• Core Capabilities:
Regulatory and Client audits: Handled around 50 audits and gained Good Experience in lead role in handling
regulatory inspections and client audits. Managed audits from, Saudi FDA, MOH from GCC countries, Pakistan
MOH, and client audits by Abbott
Drug formulation and formula design. In pilot manufacturing of solid, sterile, and liquid dosage forms. Drug master formula
construction. Batch manufacturing record build up and checking. Ordering the required materials for pilot drug
manufacturing. Intra-department coordination and planning. Formulation Development for ANDA (Abbreviated New Drug
Application) (USA) and in CTD (Common Technical Documents) format dossier for other regulated market. Development of NDDS
(Novel Drug Delivery System) platform technologies. Continue quality improvisation and Gross Contribution improvement of the
existing products. From conceptualization to commercial manufacturing of new products/molecules. Total PERT(Program
Evaluation review Techniques) charting of all related activities and continuous monitoring of the same. Technical supports to the
other related function like Production, Regulatory, Marketing, and Purchasing. Technology Transfer. Project Management.
Regulatory Documentation. Well familiar with ERP (Entry Resources Planning) and MRP (Material Resources Planning) Systems.
Developed 10 products with 10 formulation development pharmacists in one year.
Finance Costing, Purchase.
Management information system monitoring and coordination. Project management and Techno Commercial aspects.
Managing the production of small and large volume parenteral formulations and manufacturing filling and packing of sterile
products. (Eye / Ear & Nasal Drops. Skin Cream, Eye Ointments, Syrups, All kind of Semi Solid Products, Tablets
Granulation, Tablet Compression, Tablet Coating, Tablet Polishing, Capsule Filling and Packaging Process).
Managing & supervising the pre-production jobs such as washing and dry heat sterilization of ampoules & vials, moist heat
sterilization of sterile area utensils & requirements. 24 Hours 40 staff with 2 shifts system. Personally validated to work and
observe in class 100, 000 sterile plus observing and managing staff operation under class 100 LAF system.
Ensure that operations are performed as per established SOPs and in accordance to cGMP, safety guidelines, policies, other
regulatory requirements and ensuring compliance to laid down specifications of cGMP & Standard Operating Procedures.
Implementing quality plans in co-ordination with production teams; enabling achievement of quality targets, preparing
internal audit schedules. Member of Hygienic and safety committee.
Responsible for organization and planning activities of warehouse, Standard Operating Procedures (S.O. Ps) for smooth
functioning of department, generation of inventory on monthly and yearly basis with finance auditors, proper deposition of
rejected materials and handling vehicles related to warehouse. Coordinating with Purchasing, Finance, warehouse, Quality
Assurance and Engineering departments (PED and FED), distributors, marketing, exports sales, Production departments &
factory Lab on various relevant matters. Well familiar with MRP and ERP System.
NOTE: The existing warehouse in Riyadh Pharma is fully automated. Warehouse designed and installed by Morris
Warehouse Management System. UK.
Head of Purchasing, PPIC, Logistics and warehouse departments. Member of vendor qualification auditor’s team. Managing
and monitoring daily Operations activities in the departments. Inventory reports, Production Planning reports on daily basis.
Supervising Product Planning and Inventory Control, Purchasing department, Coordinating with QA for vendor
qualification issues. Monitoring the activities in Warehouse. Supervising the logistics department on transportation and
custom clearance issues. Supervising the dispensary for dispensing ingredients, APIs of products for production. The
Production Planner is a key link between Manufacturing Operations, Material Procurement and Planning, Quality, Sales,
and Development to drive schedule alignment, priorities, and overall supply chain execution. Prepare master production
schedules, production work orders, and manage finished goods inventory levels for a network of manufacturing sites and
distribution centers.
Machinery Handled at Riyadh Pharma:
Krieger (fully automatic) sterile / non-sterile Creams, Ointments manufacturing vessel from Switzerland. Diesel
Manufacturing Vessel for Eye, Ear and Nasal Drops. Diesel Fat melting machine. Diesel Manufacturing Tank for Syrup
Line, Diesel Filling tank for Syrup Line from Germany Gmbh. IMA (fully automatic) Filling machine and Marchesini
Packaging machines Comadis cream, ointment and eye ointment filling machine from Italy. Becomix Manufacturing
vessel for Eye ointment, Skin Creams from German GMBH... Groningen filling and stoppering machine from Germany.
Delama Autoclave -Italy. Autoclave Validation- Integrity Air Intake, Porous Load and Non-Porous Load, Steam Quality
test, requires Load Cycle like Garment load, sterile syringe pump for vial and ampoule filling. Filter Integrity-Sartorius and
Plantronics Filter Integrity testing machine for parenteral products. Manually Integrity test for Filter for Parenteral like
Bubble point test. Automatic Vial Washing and Tunnel Sterilizer attached with vials filling machine. (Groningen machine
from Germany). DQ, IQ, OQ, PQ for all new machines and Area.
Reason for Leaving: Had been part of team of consultant to build up new Pharmaceutical factory from ground zero,
limited opportunities for progression, seeking new challenges.
Documentation:-
URS of all kind of Equipment Machine, Validation Protocol for products and Machines, CAPA, Deviations, BMRs, BPRs,
SOPs. Vendor Qualification and audits. Drug Master Formula Files, CTD, IQ, OQ, DQ. Technology Transfer Files,
Packaging material development. Master Formula Development. Quality Risk Management, GMP committee. PPIC
documents, Process Development & Validation reports of all equipment’s. Improving on and updating processes to identify
areas of cost reduction and yield enhancement. Coordinating with QA for the validation of various equipment's. QCD
Mixing process for filling & sealing tubes, Drops and Syrups. QCD Washing process for vials and Sterilization by chemical
& microbiological methods. Coordinating with PED / FED technicians for the validation of LAF. Validating autoclaves,
tunnel sterilizers and lyophilizes CIP and SIP validation) regularly. Reviewing regulatory documents required before
scheduling product, conducting Self inspection audit, reviewing BMR/BPR, Production Manual and product validation
reports.
Audit Faced (Experience):
Under mentioned National and multinational company’s audits have been faced in my whole service carrier.
Laboratories
Responsible for the administrative routine in the quality control laboratory, coordinate the review & analyses of raw
material, Bulk and finished product’s specifications, packaging commodities, validation samples and approval of Purchase
samples and suppliers for procurement of materials. Providing support to Quality Affairs Director in investigating and
responding market complaints. Coordination with the production, packaging managers, Product Development Laboratory
director in all matters concerning production, introduction to new products and Coordinating with QA Managers for the
GLP (Goods Laboratory Practice) compliance and ensure GLP compliance in the labs. Supporting QA in conducting
external audits and inspections and for accomplishment of corrective actions. Developed and established Master Vendor
Approval Plan. Assessment of new vendors for GMP compliance as per the Master Plan. Generating and updating SOPs as
per FDA recommendations. Performance evaluation of sub-ordinates.
Overall Quality Management of Sterile and Non-sterile manufacturing: Quality Risk Assessment, Deviations,
Change Control, Customer Complaints, Vendor development, Return Goods, Recall and Documentation Control,
Self Inspection, Product Quality Reviews (PQR), Batch Release, CAPA etc.* Vendor Audits: Conducted more than
30 vendor audits in India, Europe, Middle East as part of vendor Qualification and thorough knowledge of Vendor
Qualification.* Handling customer complaints, Quality investigations (manufacturing and OOS investigations).*
Hands on experience in all Validation activities - Equipment validation, Computer Validation (ERP, Building
Management Software, Automated Warehouse Management software), Process Validations and Cleaning
Validation.* Good Experience in Aseptic process validation, autoclave validation, media fill etc. *Managing overall
functionality of QA, while playing an integral role in site's operational success and profitability through the early
detection of quality deficits, avoiding costly errors.* Regulatory submissions of new products and variation filing
(Quality review). * Supervise all day to day Quality Assurance activities. (Document review, Batch Release,
Vendor Qualification Validation and Audits).* Handling of deviations and corrective actions assess the impact in
quality of each deviation prior to the final decision of the QA Manager.* Handling of Change Control - Reviewing
and assessment of changes, which have any potential impact on GMP prior to the QA approval.*.Handling external
regulatory and licensor audits. * Initiating CAPA and monitoring and implementation. * Involving in handling of
customer complaints including the corresponding investigation and corrective measures and trend compilation * As
a member of company audit team, auditing all procedures, systems and facilities including to GMP and
encompasses the manufacturing and control of pharmaceutical products within company and reporting to Factory
manager and keeping records of deviations and corrective measures. * Leading role in Product Quality Review and
trend analysis and reporting to Factory Manager. * Preparing and updating Quality Manual and Site Master File. *
Training sessions conducting for subordinates and other Technical Department for Quality System SOPs and GMP.
* To prepare Annual Vendor audit and re audit plan. * Vendor Qualification procedures.* To ensure regular QA
Inspection for QC, Production Engineering, Facilities Engineering and Materials Departments and notify the GMP
deviations to the concerned Managers.
* Manage all QA Department including 40 staff (4 Senior Supervisors, 2 Supervisors and 24 Staff)
* Leading role in technology transfer of products from multi-national companies. Project Manager of QMS-LIMS
implementation.*Responsible for Documentation, Validation, In-Process Control, Batch Release, Vendor
Qualification, Complaints, Handling Regulatory Audits, Licensor company audits, Vendor audit
Equipment and Machinery handled at AJA Pharma:
Performed IQ, OQ, PQ for the following machinery along with manufacturer engineers and performed validation protocol
with QA Validation department:-
(1), Capsule filling machine type Module
. Cap induction sealing machine model M 2800. 4). Korsch single and multi-layer tablet compression machine Type XL
400 MFT (Multi-function Plat Form) by Korsch AG Berlin Germany 5). Liquid syrup manufacturing line comprising of 3
no of vessels sugar, product and CIP system by WH
procuring the medicine and other requirements of clinics & Pharmacies for all Conference
Palaces in Saudi Arabia. Updating the records for Clinic Medical Equipment and Laboratories instruments. Arranging all
necessary Pharmacies & patient records. Member of Palace Health, Safety and Hygiene. Conducting the First Aid Training
for all Palaces Staff. Inventory of medicine on daily, weekly, monthly and annual basis.
Reason for Leaving: Got better chance in pharmaceutical Industry as I was working in Manufacturing and in quality
control.
Have passed MBA from AgricultreUniversity of Faisalabad Pakistan
in
in
board of
board of
courses: Diploma in Typing Course from Kamalia Pakistan in 1990.
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