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Atul Kulkarni

Director at ARK pharma services ltd. UK

VISION & MISSION

To be best in quality and most trusted Pharmaceuticals Support Services.

To create a platform where all possible solutions are available for Pharmaceutical Industry

Education & Training

  • Pharmacy Year 2002.
  • QP Qualification, RSSL University London, Year 2019.
  • Member of RPS (Royal Society of  Pharmaceuticals UK), since the year 2014.
  • As a RP – Responsible Person on WDA Lic. In UK : 10+ Years
  • As an QP – Qualified Person on MIA  Lic.in UK : 4+ Years
  • As a Rpi – Responsible Person for Import on WDA Lic. In UK :2+Years

Techinical Skills

  • Expert in PQS
  •  GMP/GDP expert
  •  RP & RPi
  •  GMP/GDP Lead auditor
  •  GXP Supplier Management
  •  GDP Transport Validation
  • GDP Supply Chain Management
  • QA & QC leadership
  • Project Management on Global scale

Professional experience

  • 20+ years of working experience in pharmaceutical quality for highly regulated US/UK/EU/MENA global markets.
  • I was involved in various Quality projects implementing a high level of quality standards and achieved organization goals to ensure
  • patient safety and enhance the business. Key member of global harmonization project team focused on corporate quality compliance.
  • Experience in leading the Quality function in UK for 10 + years & Compliance team ensuring implementation of high-level EU GMP/GDP
  • standards and harmonizing PQS.
  • Performing QP, RP & RPi duties for the UK market.
  • Conducting corporate inspections across group sites/affiliates ensuring GMP/GDP compliance.
  • Managing and hosting regulatory GMP/GDP inspections.
  • Hands-on experience in ensuring manufacturing compliance of cGMP and in-house SOP procedures. CAPA effectiveness monitoring. Preparation, and review of annual & monthly schedule of self-inspection (announced/unannounced). Conducting internal audit as per cGMP guidelines.
  • Quality systems: Preparation and review of quality systems documents such as; SMF, VMP, VPP, QTA, Change Control, Deviation Control, Out of Specification (OOS), Out of Trend (OOT), Out of Calibration (OOC), CAPA, Product Quality Reviews, Statistical techniques and Documentation control.
  • Experience on monitoring, execution, and review of equipment, instruments, utility qualification protocols & reports such as URS, DQ, IQ, OQ, and PQ.. Quality control testing
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