Protik Biswas

Protik Biswas Email and Phone Number

Quality Assurance Manager @ Pristine Pharmaceuticals
Dhaka, BD
Protik Biswas's Location
Dhaka, Bangladesh, Bangladesh
About Protik Biswas

Highly motivated and results-oriented QA professional with a Master's in Pharmaceutical Technology and over 7 years of experience ensuring patient safety through meticulous quality control. Proven ability to lead and mentor teams, manage all aspects of QA, and ensure compliance with international GMP regulations (US FDA, EU GMP, UK MHRA, etc.).Leadership & Expertise:Successfully supervised and mentored QA teams, fostering a collaborative environment that consistently met GMP and quality standards (Deputy Manager, Pristine Pharmaceuticals Ltd.).Full QA Spectrum Management:Conducted internal audits, managed deviations, CAPA plans, and product complaints, and maintained total process assurance across diverse product types (solid, liquid, and injectable) at Eskayef Pharmaceuticals Ltd.I reviewed and approved batch documents as a Qualified Person (QP), demonstrating deep knowledge of regulatory requirements and quality standards.International Regulatory Compliance:Extensive experience working with international GMP regulations, with successful completion of audits by UK-MHRA, Novo Nordisk GMP, and US-FDA (mock inspection).Commitment to Continuous Learning:Certified GMP Auditor (Globally) demonstrating dedication to mastering best practices in quality management.Technical Expertise & Communication:Possesses an in-depth understanding of various pharmaceutical manufacturing processes and in-process testing techniques.Proficient in data integrity principles (ALCOA+) and communication skills (written/verbal) in English and Bangla.Seeking a challenging role:Passionate about contributing to a culture of quality excellence in a reputable pharmaceutical company.

Protik Biswas's Current Company Details
Pristine Pharmaceuticals

Pristine Pharmaceuticals

View
Quality Assurance Manager
Dhaka, BD
Website:
ppharmabd.com
Employees:
17
Protik Biswas Work Experience Details
  • Pristine Pharmaceuticals
    Quality Assurance Manager
    Pristine Pharmaceuticals
    Dhaka, Bd
  • Pristine Pharmaceuticals
    Deputy Manager Quality Assurance
    Pristine Pharmaceuticals Dec 2023 - Present
    Bscic Industrial Area, Mazgram, Patuakhali-8600, Bangladesh.
    Major duties include:1. Handling deviations, change requests, OOS, OOT, incidents, CAPA, and product complaints.2. Assisting in maintaining total process assurance.3. Performing in-process control activities for various dosage forms.4. Managing the Quality Management System (QMS), audits, and safety information.5. Releasing finished products as a Qualified Person (QP).6. Perform various risk assessment regarding QRMThe role also involves:1. Ensuring proper raw material use and line clearance procedures.2. Monitoring production against authorized records and reporting deviations.3. Coordinating sample collection and analysis with the laboratory.4. performing and participating in audits of various departments and vendors.5. calibrating and validating equipment, setting product specifications, and reviewing existing specifications.6. Monitoring reworks and rejections and ensuring non-viable particle control.7. reviewing and approving documents, participating in regulatory audits, and overseeing outsourced manufacturing.8. Preparing annual product quality reviews, performing internal audits, and ensuring data integrity.9. Training new personnel and assisting colleagues.10. Supervising and monitoring the activities of QA personnel.
  • Eskayef Pharmaceuticals Ltd.
    Assistant Quality Assurance Manager
    Eskayef Pharmaceuticals Ltd. Jan 2020 - Mar 2023
    400, Squib Road, Industrial Area Tongi, Gazipur, Bangladesh
    1. Managed all aspects of quality assurance for assigned product lines, ensuring compliance with GMP regulations.2. Conducted audits of various plant sections to identify and address potential quality issues.3. Performed data integrity activities in accordance with ALCOA+ principles.4. Participated in process validation and cleaning validation for pilot and commercial batches.5. Prepared Annual Product Quality Reviews (APQRs) by analyzing critical in-process and finished product data
  • Eskayef Pharmaceuticals Ltd.
    Senior Executive Quality Assurance
    Eskayef Pharmaceuticals Ltd. Jan 2018 - Dec 2019
    400, Squib Road, Industrial Area Tongi, Gazipur, Bangladesh
    1. Managed quality control (IPQC) activities for assigned production lines, ensuring adherence to SOPs and batch records.2. Investigated deviations and OOS results to identify root causes and implement corrective actions.3. Performed equipment calibration and validation activities.4. Monitored and maintained document control systems for BMRs, BPRs, PDS, and other quality documents.
  • Eskayef Pharmaceuticals Ltd.
    Quality Assurance Executive
    Eskayef Pharmaceuticals Ltd. Jun 2016 - Dec 2017
    400, Squib Road, Industrial Area Tongi, Gazipur, Bangladesh
    1. Perform in-process quality control tests to ensure product quality throughout the manufacturing process.2. Maintained accurate documentation of all quality control activities.

Protik Biswas Education Details

Frequently Asked Questions about Protik Biswas

What company does Protik Biswas work for?

Protik Biswas works for Pristine Pharmaceuticals

What is Protik Biswas's role at the current company?

Protik Biswas's current role is Quality Assurance Manager.

What schools did Protik Biswas attend?

Protik Biswas attended University Of Asia Pacific, University Of Asia Pacific.

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