SANDEEP ANDHARI

: F1/001, Jumbo Darshan, Jiva Mahale Marg, Andheri East, Mumbai, India-400069
: +91 9879112293 ~ : [email protected]

SENIOR PHARMA QUALITY PROFESSIONAL

 Glo ba l Re gu la t ory In t e l lige n ce  S tra te gi c D ire c ti on & C on tr o l  G MP C om p lia nce 

Senior Pharma Quality Professional has over 25 years of Experience in quality management, supervision, regulatory compliance, and
interpretation within quality-focused global pharma environments. Established Independent GMP Consultant, Auditor, and trainer for API,
Non-Sterile & Sterile dosage pharma units, excipients & primary packaging materials manufacturers for more than nine years.

Steered operations managing overall Quality systems and compliance: Includes auditing, validations/qualifications, Investigations and
CAPA, PQR, OOT, OOS, and risk management as per ICH Q7, 21 CFR part 11, EU guide, and PIC/S requirements across pharmaceutical companies,
including Lupin, Knoll, Abbott, Sun Pharma, Micro labs & Astral Steritech.

ABRIDGMENT
• Qualified Regulatory Subject Matter Expert with over 30 years of cross-functional experience in Project Management, Commercial
Team, and Stakeholders’ Management to ensure regulatory compliance. Adept in implementing regulatory strategies and activities
as required for the development projects; coordinated with all functional groups to ensure awareness of regulatory and quality
requirements
• Skilled GMP Auditor; performed more than 200 GMP audits & gap audits of API, formulations (sterile and non-sterile), Analytical
testing laboratories, R&D and distribution depots, primary packaging materials & excipients as per ICH Q7, US FDA, EU GMP, IPEC,
WHO & ISO guidelines including EU QP liaison audits and international audits.
• Proven abilities in international GMP audits of API & formulations and traveled to China, Japan, Malaysia, Taiwan, Spain &
Bangladesh; rendered training to over 10000 pharma professionals on GMP, Quality, and related topics including US cGMP, EU
GMP, ICH Q7, Data Integrity, Documentation Practices, Internal Audits, External Audits, & Quality Culture & risk assessments
• Good experience & skills in desktop & virtual audits.
• Extensive knowledge of GMP guidelines and quality management systems like ICH Q7, ICH Q8, ICH Q9, ICH Q10, ICH Q11, 21CFR part
11, 21 CFR PART 210 & 211, EudraLex- Volume 4, WHO, PICS, IPEC and ISO; acted as a primary host for USFDA, EDQM, LACHMAN,
MHRA as well as WHO Geneva
• Conducted review of Critical SOPs, Deviations, Investigations, CAPA, validations, and qualifications in new projects, PQR, OOS,
OOT, Stability, Batch Manufacturing Records, Analytical Records, Specifications and Risk Assessment

SIGNATURE SKILLS
~ Strategic Planning ~ Global Regulatory Intelligence ~ Regulatory Submission Management
~ Data Generation ~ Statutory Compliance ~ Stakeholder Management
STRATEGIC
~ Market & Product Analysis ~ Process Setup & Optimization ~ Government Affairs
~ Techno-commercial Support ~ Risk Management ~ Documentation & Reporting

~Facility Qualification & Validation ~ Establishment of QMS ~ Quality Audits

DOMAIN ~Simplification of Procedures ~ Technical Writing ~ Data Integrity Assessments

~ Sustainable Solutions ~ Laboratory Controls ~ Investigations Review
~ Vendor Quality Management ~ Training on Quality & compliance ~ Risk assessments

Analytical Problem- Interpersonal Leadership

Communication Time Mgmt.
Skills Solving Skills Qualities

EMPLOYMENT CHRONOLOGY

Aug 2011 – Till date - Founder & Managing Director of A Plus Pharma Consulting (Independent GMP Consultant, Quality
Auditor & Trainer)

Key Result Areas

• Developing & implementing the Quality Department’s strategy to ensure it meets business requirements and customer deliverables;
ensuring departmental performance against set goals
• Overseeing the development of departmental SOPs (writing, revising, and approving); preparing the Quality Department’s budget
• Ensuring that the Quality Department meets targets set for budget, cost, volume, and efficiency in line with business objectives
• Facilitating alignment of departmental objectives and activities with quality system & strategic objectives
• Building & maintaining a Quality Risk Management System to control risks adequately; ensuring harmonization between Chemical
& Formulations processes; establishing effective audit programs; managing all validation activities, including validation strategy &
approval of protocols
• Facilitating Product transfer including requirement analysis, finalizing testing procedure, conducting feasibility studies; setting up
laboratories from scratch
• Monitoring strict adherence to regulatory guidelines & standards
• Reviewing analytical documents, SOPs, general test procedures, protocols, and their summary reports; ensuring appropriate
maintenance of documentation such as registers and files, formats, and training records
• Providing direction and guidance to the Quality & technical Team; managing, motivating, coaching, and mentoring.

Significant Highlights/Achievements
• Pivotal in leading operations as Subject Matter Expert/Super Specialist on QA, QC, and manufacturing systems in API, non-sterile
formulations, excipients & primary packaging materials.
• Successfully established manufacturing & quality assurance procedures and documentation in alignment with prevailing regulations
• Rendered training to more than 10000 workers, officers, executives & senior management on GMP, Quality & Compliance Issues.
• Mentored the QA/QC/Manufacturing team during external audits and regulatory inspections resulted in many US FDA, EDQM, WHO
GENEVA, MHRA, EU & EXCiPACT accreditations.
• Stellar role in providing scientific guidance to resolve issues related to inspectional findings; reviewed Critical SOPs, deviations,
Investigations, CAPA, validations, and qualifications in new projects, PQR, OOS, OOT, stability, batch manufacturing records,
analytical records, specifications, and risk assessment.
• Performed more than 200 GMP audits /gap audits of API, formulations (sterile and non- sterile), Analytical testing laboratories,
Primary packing materials, Excipients, and R & D and distribution depots as per ICH Q7, US FDA, EU GMP, WHO, IPEC & ISO guidelines
including EU QP liaison audits and international GMP audits.
• Maintained cordial business relations with Indian & International Clients.

PREVIOUS WORK EXPERIENCE

2010-2011 associated with Astral Steritech Private Limited as General Manager -Quality Control

2010-2011 associated with Micro Labs Limited as General Manager -Quality Assurance

2006-2010 associated with Sun Pharmaceuticals Limited as Senior Manager Quality Assurance

2002-2006 associated with Abbott India Limited as Manager Quality Assurance -TPM

1990-2002 associated with Knoll Pharmaceutical Limited as Head Quality

1985-1990 associated with Lupin Limited as Quality control officer

ACADEMIC CREDENTIALS

B.Pharma. From Govt. College of Pharmacy, Karad, Maharashtra, India in 1984 with 1st class
ISO 9001:2015 Quality Management System (CQI & IRCA certified ) Lead Auditor
Bodhih Certified Trainer: Train The Trainer Certification
Published papers on pharmaceutical analysis in reputed journals.

PERSONAL DETAILS
Date of Birth: 04/03/1964 | Permanent Address: J-203, Vicenza 51, Near Kalali Water Tank, Vadodara, Gujarat, India - 390012