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