Shaik Sikander

Across more than a decade, I have cultivated a profound reservoir of expertise by positioning myself as an adept Quality Specialist within the scientific disciplines of Medicine Formulation Facilities and in Supply Chain management. (Facilities approved by: USFDA, EUGMP, WHO, MHRA, MOHAP, and other reputed regulatory bodies). 

By holding a sound understanding of quality elements, I am being in establishment and governing the GxP systems in accordance with principles and regulations, and consistently striving to contribute my skills in the challenging roles

• Presently working as a QA- Officer for Pharma, Medical Devices, Dental, and Nutrition Products Distributor since 2+ years.
• Worked for Medicine Formulation Industries around 8+ years. Expert in handling a wide range of FPP’s such as Injectables, Tablets, Capsules, Softgels, and Pellets.

 Quality Assurance- Officer

City Pharmacy LLC. (Distributor of Pharma, Medical Devices, lab, Dental and Nutrition products). [11 Oct 2020 – Current]

City: Sharjah

Country: United Arab Emirates

• Accountable for GxP compliance during receiving, storage, picking and packing, and dispatch of TTSP’s to maintain sustained product quality and operation systems.
• Accountable for the shipment's release.
• Responsible for SOP, QMS, training, self-inspections, risk assessment, qualifications, preventive maintenance, and mapping of pharmaceutical products (storage area, cold chain containers, and vehicles).
• Hosting supplier and customer audits.
• Initiating, reviewing, and monitoring BCP mocks and WH KPIs.
• Managing activities involving recalls, damaged, returned, and expired items.
• Monitoring of thermal conditions (ambient and cold chain) throughout the medicine supply chain adheres to product-specific labeling and standards.
• Qualification of suppliers and service providers.
• Handling of supplier and customer queries pertaining to quality elements.
• Updating and implementation of GDP and GSP systems in line with MOH, WHO, EU, ISO, and UNICEF guidelines

Quality Assurance - Executive

Geltec Health care FZCO. (OSD Manufacturing Plant). [18 Dec 2017 – 12 Sep 2020]

City: Dubai

Country: United Arab Emirates

• Accountable for developing and ensuring that production facilities comply with regulations.
• Responsible for Change controls, Incidents, Deviations and CAPAs, Self-inspection, Training, Process validation, Hold time studies, Cleaning validation, Artwork reviews, and Document control.
• Equipment, vendors, and External services providers Qualification.
• Review and approval of Quality Technical Agreements, Supplier Agreements, Quality Manual, SMF, VMP and Product dossier for RA submission.
• Responsible for SOPs, MFRs, BMRs, BPRs, APRs, and Quality trends preparation, review and update.
• Responsible for Stability, COA, Specifications, STPs Compliance.
• Responsible for Raw Material and packing material code allotment. IP and FP Batch formula creations in ERP.

Quality Assurance -Associate

Dr. Reddys Ltd. (Sterile and OSD Manufacturing plant). [22 Jul 2013 – 8 Oct 2017]

City: Hyderabad

Country: India

Quality Management Systems:

• Review, approval, and monitoring of Change controls, Incidents, Deviations, and CAPAs by QMS Software
• Handling of market/customer complaints.
• Coordinating with Contract givers and customer reg. notifications of quality elements and clarifying technical queries (Customer support).
• Notifying/sharing plant QMS subjects with regulatory Agencies.
• Preparation and final review of quality trends.
• Involved in the preparation of QRM/Impact/Gap Assessment Reports (Formal and Informal).

Qualifications:

• Quality compliance with respect to Site Validation master plan.
• Preparation and review of equipment qualification and revalidation protocols and reports.
• Accountable to program Quality Risk Management for new Equipment, Products, Method, System and Process
• Responsible for equip. qualification: Autoclave, Drying tunnel, HVAC, Water system, Vial washing m/c.
• Responsible for reviewing and approving the Site master file, Validation master plan, Master calibration plan and Preventive maintenance schedule.

Shop floor Quality monitoring:

• Monitoring of Component preparation area, Sterilization process, and Compounding, Filtration, Filling, Inspection, and Labeling & Packing activities of SVPs.
• Handling of NVPC in Aseptic and Non-aseptic areas
• Involved in aseptic Media Fill processing and documentation.

Sr. Quality Assurance Officer

HETERO Labs Ltd. [5 Nov 2011 – 11 Jul 2013]

City: Jedcharla

Country: India

Shop floor Quality monitoring:

• To give line clearance at various stages of manufacturing, packing, and dispensing by making sure the standards are met.
• Executing in-process inspections to guarantee that manufacturing and packing processes are carried out in accordance with the established procedures.
• Sampling of in-process, bulk, finished, retention and stability samples for QC as per the protocol.
• Responsible for the calibration of Calibration of Disintegration test apparatus, Friability test apparatus and weighing balances.
• Carried out AQL and pack stock tasks.
• Ensuring the proof check during packing activities
• Final review of BMRs, BPRs, and Analytical reports for giving FGTN.
• Verification of Release Documents and Consignment before dispatch of products.
• Execution of Process Validation, Cleaning Validation, and Hold time study as per the protocol.

B-Pharmacy at annamacharya college of pharmacy