Ajai B. Email & Phone Number

Hyderabad, In

Dubai, United Arab Emirates

Advise clients/entrepreneurs on QMS, GMP, and Commercial excellence.» Adept at gap assessment/deficiency evaluation of internal documents, business agreements, standards, and compliance with regulations.» Overview and governance of business agreements, change management and its process flow compliance and potential SME for Business Continuity Planning, and lean management.» Identify potential partnerships, collaborations, or acquisitions that align with the company's objectives.» Analyze market trends, and identify potential business opportunities and assess the competitive landscape within the pharmaceutical industry.» Assess customer needs, market segments, and potential areas for growth and develop strategic plans to penetrate new markets, and expand existing market share.» Strategize procedures and marketing process to increase profitability.» Collaborate for sourcing of suppliers for APIs, PMs, Logistics, WH, and Distributors.» Facilitate organizational training and capacity-enhancement programs.»

Dubai, United Arab Emirates

Key Result Areaso Governed global quality operations of CMOs for medical device and cardiovascular products across Europe, UK, and North America.o Directed the activities of the QC/QA teams to ensure that raw materials, In-process, and finished products meet quality specifications.o Oversaw laboratory operations, ensuring all testing for medical devices and pharmaceuticals is compliant with regulatory requirements.o Optimized process efficiency and quality compliance by providing expert input and troubleshooting advice on QMS, KQIs, audits, and data integrity, resulting in improved operational standards and reduced risk.o Facilitated validation and qualification of equipment, and processes, as per established protocols and standards.o Developed, implemented, and maintained an integrated Quality Management System (QMS) that complies with ISO 13485 for medical devices and cGMP (21 CFR Parts 210/211) for pharmaceuticals.o Ensured the QMS alignment with international regulatory requirements such as FDA, EMA, and other applicable regulations.o Leverage expertise in quality management to assist companies and entrepreneurs in developing robust audit frameworks and preparing internal documentation for compliance verification and improvement as per EU GMP and MHRA UK.o Led initiatives to streamline processes and enhance operational standards, contributing to overall organizational excellence and performance.o Directed a Qualification program for API suppliers and potential CMOs led supplier audits and managed quality agreements with third-party vendors.• Reduced product recalls to 0.1% by introducing new manufacturing process controls, significantly enhancing product quality and safety.• Established a robust supplier and contract manufacturer qualification process, ensuring suppliers meet the quality standards for raw materials, APIs, and contract-manufactured products.

Dubai, United Arab Emirates

Key Result Areaso Led quality oversight for a medical device manufacturing facility, managing QA/QC functions, and compliance as per MOH UAE regulations.o Developed, implemented, and maintained the site’s Quality Management System in compliance with GSK’s global standards, ISO 13485, and other relevant regulatory requirements such as cGMP, HACCP, HALAL, 22716, and 17025 standards.o Governed all medical devices produced at the site and met the required specifications and quality standards.o Monitored the key quality metrics and drove initiatives to achieve and exceed site quality objectives.o Played a key role in internal audits, safeguarding data integrity, delivering quality and safety training, and waste management efforts.o Managed non-conformance reports (NCRs) and oversaw the RCA process and implementation of corrective actions.o Developed and maintained a robust supplier quality management program, including the qualification, auditing, and monitoring of suppliers.o Led initiatives to improve quality processes and product quality, using Lean Six Sigma or other continuous improvement methodologies.o Coordinated with top management and stakeholders through periodical Quality review and management review meetings.o Facilitated the process validation of pilot and commercial batches, and equipment to ensure consistent product quality.o Led the preparation for regulatory inspections and audits and ensured the timely submission of all regulatory documents with compliance.o Led the site’s risk management activities, including identifying, assessing, and mitigating potential risks to product quality and patient safety.o Managed specifications for raw materials, semi-finished goods, finished goods, and packing materials, artworks, and reviewed and approved SOPs, STPs, ROAs, MSDS, and COAs, ensuring timely batch releases.o Collaborated with cross-functional teams, including R&D, manufacturing, and supply chain.

Hyderabad, Telangana, India

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Provided strategic direction to the team in conducting bio-similar product testing of the drug substance. ❖ Led QMS to increase customer satisfaction through high product quality. Ensured cGMP compliance during manufacturing of biosimilars while serving as compliance officer. Prepared DS and FGs, including stability studies, medial fill/methods validation, vendor qualifications, and water system. ❖ Make sure the readiness of team for “Any-time audit preparedness” and in-depth regulatory inspections from GlaxoSmithKline, QP UK, MERCK SERONO, MOH UAE, MHRA, INVIMA, and ANVISA.❖ Formulated and optimized rapid microbial methods for analytical capability building which minimized duration of testing and quick-lot release. Conducted thorough investigation on repeated root causes to implement CAPA for repeated microbial testing failure. ❖ Managed efficiently CAPEX and inventory control, annual budgeting, annual performance appraisals, and rapid sterility testing methods.❖ Minimized the cost by ~35% of lab analysis, through innovative procedure or process simplification strategies.❖ Reduced turn-around time for microbial analysis of biosimilars through establishment of rapid microbial methods.❖ Implemented efficient CAPAs for repeated BET failures via thorough Root-cause analysis.

Hyderabad, Telangana, India

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Headed a team for product testing for DS, FDS & DP through microbial analytics (Sterility Testing, BET, Bioburden & Environmental Monitoring, monitoring of assay performance and Investigation of Non-conformance and OOS/OOL/OOT); ensured timely completion of lot release assay and batch release, performance review, Management of GMP document preparation (SOPs, RSTs, ROAs, BMRs, BARs, JDs, Validation documents, etc.), Medial fill validation, method validation, vendor qualification, area qualification and water system qualification, Ensuring 100% compliance on GDP and GMP requirements for “Any-time audit preparedness”, Data Integrity compliance, Incident investigation, safety observation & Audit, Auditing: Internal and external, including customers and regulatory bodies, Internal Training management, IPQA controls, Vendor evaluation, supporting for APQRs preparation, CAPEX, annual budget preparation and cost-saving proposals, Annual performance review.𝑺𝒊𝒈𝒏𝒊𝒇𝒊𝒄𝒂𝒏𝒕 𝑨𝒄𝒉𝒊𝒆𝒗𝒆𝒎𝒆𝒏𝒕𝒔» Significantly reduced the “turn-around time (TAT) for microbial analysis of biosimilars by establishing rapid microbial methods.» Proven track records of no major or critical observations during regulatory / customer inspections from GSK, QP UK, Lachman US, MERCK SERONO, MHRA UK, INVIMA Colombia, and ANVISA Brazil.» Achieved the significant reduction of QC laboratory analytical cost by ~35% by implementing the simplified procedures.» Effectively reduced and optimized the non‐value‐added sampling & analysis at In‐process stages without compromising quality.» Accomplished 98% of on-time closure of QMS reports by streamlining the investigation process with cross functional teams.» Appreciated for implementing efficient CAPAs for repeated BET failures, deviations by human errors and laboratory errors.» Implemented latest techniques & procedures for achieving operational efficiency and improved quality standards & cost savings.

Himachal Pradesh, India

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Played a key role as a QC Microbiology head, spearheaded a team of seven members, involving in routine microbial and chemical analysis and batch release. ❖ Managed GMP compliance, quality management systems, auditing, training, environmental monitoring, water system management, environmental safety and health compliance, and product failures investigation in co-ordination with drug control departments and higher officials on product complaints.❖ Implemented sustainable quality management systems and conducted microbial QC analysis in conjunction with qualified team members of probiotic product testing facility.❖ Built R&D facility for probiotics (Lactobacillus, Saccharomyces boulardii, and Bifidobacterium sp.,).❖ Oversaw the development/commercialization of new probiotic products as well as prepared and improved stability studies for newly developed products.

Chennai, Tamil Nadu, India

> Supported the QC team in testing and validating APIs - Penicillin and Cephalosporin.> Reviewed and approved analytical methods, specifications, and validation protocols.> Oversee laboratory equipment's routine calibration and maintenance to ensure accurate testing.> Assisted in developing, implementing, and maintaining quality assurance systems and processes.> Ensured compliance with cGMP and other regulatory standards.> Monitored API production processes to ensure consistency and adherence to quality standards.> Ensured all quality-related documentation, including batch records, SOPs (Standard Operating Procedures), and testing results, are accurately maintained.> Prepared and reviewed quality reports, deviations, CAPA, APQRs, and change controls.> Participated in internal and external audits, including regulatory inspections by regulatory bodies.> Supported for timely closure of audit observations and implementation of corrective actions.

Hyderabad, India & Copenhagen, Capital Region, Denmark

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Involved on projects sponsored by Defense Threat Reduction Agency (DTRA, USA) and Army Research Organization (ARO, USA) projects to discover novel molecules with anti-viral, anti-cancer properties via combinatorial biosynthesis and to discover antibacterial molecules against Burkholderia pseudomallei, a futuristic bioweapon worldwide.❖ As a Project Manager of Anti-fungal (Veterinary Application), successfully positioned a potent anti-fungal candidate for animal pathogenic fungi, including MDR strain Scopulariopsis brevicaulis by leading a team from a CRO and a government organization for efficacy analysis, bio-distribution and MOA, animal experiments and also development of new formulation for this potent anti-fungal molecule.𝑨𝒄𝒉𝒊𝒆𝒗𝒆𝒎𝒆𝒏𝒕𝒔 :❖ Constructed 75 full length cDNS library for Opuntia, Neem, Pinus, Tamarindus, Ashwagantha and few other Indian herbal or aromatic plants for combinatorial biosynthesis of small molecules using eYAC.❖ Successfully positioned a novel class of anti-fungal molecule as a potent anti-fungal candidate against animal pathogenic fungi as Project Manager.

Mumbai, Maharashtra, India

Vadodara, Gujarat, India

M.Sc

B.Sc