Dr Jafar Ikbal kazi

Management of Quality assurance department
Approval and authorisation of Documents
team management
Batch release

QMS and Compliance and other QA related activities
Handling QA department in absence of QA manager

 IPQA team activities management(Dispensing, Mfg, Filling, packing, dispatch etc
 Preparation and approval of BMR/BPR/BDR
 Issuance of BMR/BPR/BDR
 Document management
 Vendor Qualification: qualification of vendors of packing materials, raw materials, planning & execution of vendor audits. Communication and coordination with supply chain, QC, production department for the same.
 management of CAPA & Investigations, Deviations
 Monitoring of cold chain, dispatch activities
 Releasing of batches for market, Review of QC reports and compliance
 Operation and handling of SAP. Internal audits.
 Compilation of documents for annual report submission to FDA
 Review and approval of APQR
 Handling of rejections (QC/online/warehouse)
 Review of completed BMR/BPR/log books at shop floor.
 Identification of training needs, preparation, execution and monitoring of annual training calendar
 management of control samples/stability samples/clinical trial samples
 Media fill, revision and preparation of SOPs
Monitoring compliance activities

 BMR, BPR issuance, Document retention, compilation of validation reports.
 Operation & Handling of BMR and BPR generation program.
 Validations as vial washing machine validation, tunnel sterilizer, LAF, CIP, SIP validation)
 Document Review: Review of executed BMR & BPR, review of validation reports and protocols
 Participate in investigation of deviation, discrepancies and test failures, change controls.
 Identification of training needs and imparting training with respect to GMP, GLP, Safety, Hygiene, application and principles of quality assurance
 Improving in process controls
 SOP, preparation, review, issuance, withdrawal, implementation of SOP.
 Cold chain management, monitoring batches are mfg as per GMP & regulatory requirement.
 Pre-audit preparations, sampling for process validation batches, ANDA batches

Responsibilities Handled:

 Line Clearances & Inprocess checks for different production activities \{Component sterilization & washing, Mfg. Filling, Lyophilization, terminal sterilization etc\], packing, proof checking. Media fill
 Involved in new injectable line set up \[Groninger & Co. Gmbh, Germany\], IQ, OQ, PQ.
 Product assessment\[process validation\] & aseptic process validation \[media fill\]
 Coordination & documentation part handling with R&D trial batches, self inspections
 Involved in cleaning validation, hold time study for bulk \{mfg bulk, filtered bulk\]
 Execution of registration batches & document compilation
 Co-ordination and communication with regulatory department for filing/discrepancies/deficiencies
 Manpower management for IPQA. Review of draft batch records.
 Occupational Exposure Study for cytotoxic products

Got exposure to audits as: TGA, MHRA, WHO, USFDA & other regulated & semi regulated markets

Quality control microbiology
Sampling of water
Product and raw material sampling
Microbial limit test
exposure plate and active air sampling
Area qualifications
autoclave validation
Batch record review
temperature relative humidity monitoring
FAT for equipments