Manik Islam

Manik Islam Email and Phone Number

Senior Executive; ISO 9001:2015 (QMS) & ISO 14001:2015 (EMS),5S & KAIZEN, SOP Preparation, Risk Management, cGMP, PQR,CCR,DCCR,BMR,BPR Analysis at US-FDA, UKMHRA, TGA, WHO, ISO 9001:2015 Approved Pharmaceutical Company. @ The ACME Laboratories Ltd.
Manik Islam's Location
Dhaka, Bangladesh, Bangladesh
About Manik Islam

About 7 years of Employment in Quality Management System of a leading Pharmaceutical Company ( US-FDA, UK-MHRA, TGA, WHO, ISO 9001:2015 and others Stringent Regulatory Bodies Approved). Proven experienced in QMS (ISO 9001:2015) & EMS (14001:2015) Execution, Auditing, Report writing, Risk Management, CAPA Management, SOPs preparation and ensuring compliances of Internal and External Regulatory requirements. M.Pharm in Pharmaceutical Technology, achieved Lead Auditor qualification on QMS (9001:2015), EMS (14001:2015) from IRCA, Certified on KPI & KEI setting, 5S & KAIZEN execution for Operational Excellences.

Manik Islam's Current Company Details
The ACME Laboratories Ltd.

The Acme Laboratories Ltd.

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Senior Executive; ISO 9001:2015 (QMS) & ISO 14001:2015 (EMS),5S & KAIZEN, SOP Preparation, Risk Management, cGMP, PQR,CCR,DCCR,BMR,BPR Analysis at US-FDA, UKMHRA, TGA, WHO, ISO 9001:2015 Approved Pharmaceutical Company.
Manik Islam Work Experience Details
  • The Acme Laboratories Ltd.
    Senior Executive_ Quality Management System, Iso 9001:2015 (Qms), Iso 14001:2015 (Ems)
    The Acme Laboratories Ltd. Jan 2021 - Present
    1/4, Mirpur Rd, Dhaka 1207, Bangladesh
    Duties/Responsibilities: • Develop, implement, and maintain the Quality Management System (QMS) in accordance with relevant standards, such as ISO 9001, ISO 45001, ISO 14001, or other applicable regulations.• Conduct regular audits and assessments to evaluate compliance with QMS requirements and identify areas for improvement. This involves planning and executing internal audits, analyzing audit findings, and driving corrective and preventive actions.• Collaborate with cross-functional teams to develop and revise quality policies, procedures, and work instructions. Work closely with departments to ensure that processes align with the QMS and drive consistency in quality practices across the organization.• Provide guidance and support to employees at all levels of the organization to foster a culture of quality and continuous improvement. This includes training employees on quality-related topics, providing clarification on QMS requirements, and promoting a proactive approach to quality management.• Monitor and analyze key performance indicators (KPIs) to assess the effectiveness of the QMS. Identify trends or issues that require corrective action and work with relevant stakeholders to implement improvements.• Lead or participate in investigations of non-conformities, customer complaints, and other quality-related incidents. Determine root causes and implement corrective and preventive actions to address underlying issues.• Coordinate and facilitate internal and external audits. Ensure timely completion of audit findings and effective implementation of corrective actions. Collaborate with auditors to address any non-compliance issues and improve the QMS.• Stay updated on industry best practices, regulatory requirements, and emerging trends related to quality management systems. Research and analyze changes in regulations and standards, and provide recommendations for process enhancements or changes as needed.
  • The Acme Laboratories Ltd.
    Executive, Qms & Ems
    The Acme Laboratories Ltd. Oct 2017 - Dec 2020
    1/4, Mirpur Rd, Dhaka 1207, Bangladesh
    Duties/Responsibilities: • • Ensure execution of ISO 9001:2015(QMS) & ISO 14001:2015 (EMS) throughout the Organization.• Preparation of yearly QMS and EMS Audit Program and Audit Plan, Implementation status of processes by internal audit.• Perform QMS & EMS audits and surveillance audit following ISO 9001:2015 & ISO 14001:2015 at factory, Corporate office & 29th Depots/Salecs Center throughout the country.• Ensure Audit Report preparation based on Audit Findings.• SOPs Preparation, Routine Review and Gap Analysis.• Conduct skill development & soft skill training program for all quality inspector and staff. • Develop policies, Organogram (visio), internal memo and differnt procedures including Master Procedure, Quality manual for smooth business operation.• Auditing of Warehouse, FIFO, BMR, BPR, CCR, DCCR, Anexure, NDA, ANDA, Bin Cards and Inventory management at warehouse & depots. • Assessing, notifying & Risk Management. • Maintain documents and control records in terms of distribution with acknowledgement, retrieval, storage, identification, legibility, suitability and adequacy to ensure all tiers of QMS documentation properly. • Communicate internal customers to provide information of different process improvement strategies, tools, techniques and their implementation guidance.• Maintain amd improve product quality through regulatory compliances.• Conduct regional ISO 9001:2015 training as per annual training calender.• Developing yearly training plan based on QMS requirements and facilitate the trainings for employees.

Manik Islam Skills

Clinical Pharmacy Process Validation Cgmp Practices Pharmaceutical Industry Calibration Ipc Validation Toxicology Cleaning Validation Iso 9001 Pharmacology Internal Audit

Manik Islam Education Details

  • Jawaharlal Nehru Technological University, Hyderabad
    Jawaharlal Nehru Technological University, Hyderabad
    First Class With Distinction (81% Marks)/ Cgpa 8.1 Out Of 10
  • Rajbari Govt. College
    Rajbari Govt. College
    Cgpa 4.80 Out Of 5.00
  • Ramdia B.M.B.C High School
    Ramdia B.M.B.C High School
    A

Frequently Asked Questions about Manik Islam

What company does Manik Islam work for?

Manik Islam works for The Acme Laboratories Ltd.

What is Manik Islam's role at the current company?

Manik Islam's current role is Senior Executive; ISO 9001:2015 (QMS) & ISO 14001:2015 (EMS),5S & KAIZEN, SOP Preparation, Risk Management, cGMP, PQR,CCR,DCCR,BMR,BPR Analysis at US-FDA, UKMHRA, TGA, WHO, ISO 9001:2015 Approved Pharmaceutical Company..

What schools did Manik Islam attend?

Manik Islam attended Jawaharlal Nehru Technological University, Hyderabad, Jawaharlal Nehru Technological University, Rajbari Govt. College, Ramdia B.m.b.c High School.

What skills is Manik Islam known for?

Manik Islam has skills like Clinical Pharmacy, Process Validation, Cgmp Practices, Pharmaceutical Industry, Calibration, Ipc, Validation, Toxicology, Cleaning Validation, Iso 9001, Pharmacology, Internal Audit.

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