LINCYMOL APPACHAN

EKF Life Sciences is a manufacturer of diagnostic enzymes and custom products for use in medical diagnostics, and the pharmaceutical industry. The key business areas are Fermentation, Bioprocessing, and Diagnostic enzyme manufacturing.

Responsibilities :

• Actively participates in continuous improvement activities by identifying opportunities, process gaps, and recommending improvements to the affected processes.
• Implementing strategies to improve product and process quality through quality and reliability engineering principles.
• Managed on-time execution of key deliverables like equipment and process validation, internal non-conformities, corrective & preventive actions, and root cause analysis to support strategic business growth.
• Responsible for coordinating, calibration of equipment, and confirming that inspection equipment and techniques are appropriate and align with the Quality standards.
• Ensuring cohesive maintenance of the Quality Management Systems (QMS) within the organization by associating with the implementation of software validation activities for QMS and laboratory management software.
• Conducts periodic training of employees in quality functions and is responsible for maintaining employee training matrix.
• Responsible for Quality Assurance deliverables like maintenance of eQMS software, product nonconformances, and documentation.
• Risk management, and assisting with Internal audit processes.
• Lead cross-functional team projects by planning and managing production schedules and other operational activities.

Tri-Pac is an ISO-certified manufacturing company that provides contract development manufacturing and turnkey services to marketers of aerosol, liquid, tubes, and specialty packaged products.

Responsibilities:

• Managed routine analysis of raw materials, production batches, and finished products like hand sanitizers, lubricants and other personal care products following specified analytical techniques as per approved specification procedures and US Pharmacopoeia monographs.
• Responsible for reviewing and approving batch records to ensure that the information and documentation are accurate.
• Development of analytical methods for novel formulations especially for personal care products to determine the content of active ingredients in the drug formulation.
• Instruments Handled: Gas Chromatography (GC), Brookfield Viscometer, High-Performance Liquid Chromatography (HPLC), Biolumix for microbiology analysis, Fourier Transform Infra-Red Spectrophotometer (FT-IR), Total Organic Carbon Analyzers

Syngene International is a leading India-based multi-national company, offering end-to-end discovery, development, and manufacturing services for novel molecular entities across industrial sectors including pharmaceutical, biotechnology, agrochemicals, consumer health, animal health, cosmetic and nutrition companies.

Responsibilities:

• Responsible for analysis of formulation samples that include raw material and packing material to ensure quality standards and compliance with established specifications.
• Knowledgeable in USP, cGMP, ICH, and FDA guidelines and has participated in and supported USFDA and EU audits.
• Performed Excel validation as per GMP requirements and preparation of protocols and reports.
• Proficient in SAP, MS Excel, MS Word, and PowerPoint.
• Instruments Handled: Disintegration Apparatus, Polymerized Chain Reaction machine (PCR), Ultra-violet Spectrophotometer

Worked as a Formulation development chemist and specialized in the formulation and development of oral and topical pharmaceutical products.

Responsibilities:

• Formulation and development of a range of pharmaceutical products including creams, lotions, and syrups
• Preparation and maintenance of formulation records as per statute.
• Maintaining confidentiality of derived formulae of the products.