Rincy Philip

• Areas of experience Cardiovascular, diabetology, gynecology, gastroenterology, dermatology.
• Wrote primary and review manuscripts for publication in peer-­reviewed journals.
• Coordinated and managed conclaves related to gynecology, orthopedics and wrote executive summaries for agendas of these conclaves.
• Wrote primary and review manuscripts for Pharmaceutical clients.
• Provided clients with medical writing, reviewing, and editing services.
• Ensured consistent high quality of all writing projects on allocated accounts, ensuring that relevant activities are fully compliant with required guidelines and meet the needs and objectives of the client, target audience, and communication medium.
• Guiding team members to ensure excellent outputs and timed-delivery.
• Review of scientific articles and manuscripts.
• Wrote scientific facts, news abstracts and summary points for PODCAST.
• Contributed to writing for projects, especially drafting content for complex or unusual items.
• Provided input into publication plans and work to ensure timely achievement of milestones.

• Updated SOP related to validation and hold time studies as per current guidelines.
• Implemented sophisticated and detailed Tracking System for hold Time Study that gives deep insight of the study initiated in the plan.
• Validation protocol and report preparation for tablets and Soft gelatin capsule.
• Preparation, review of protocols and reports for hold time study in different stages of its process (Tablets and Soft gelatin Capsule)
• Preparation of Risk assessment of elemental impurities in drug product as per ICH Q3D.
• Assisted in new equipment qualification, area qualification, re-qualification of equipment in the site.
• Preparation of documents involved in qualification of equipment.
• Preparation of cleaning validation protocols and reports.
• Performed sampling of batches in different stages as per approved protocol for validation batches.
• Swab sampling for batches considered for cleaning validation.
• Contributed in preparation of validation master plan.

IPQA Activities:

• In- Process checks for bulk tablets and capsules.
• Sampling of bulk tablets and capsules and preparation of its physical parameter testing reports.
• Line clearance of primary and secondary packaging lines.
• Point sampling of blends.
• Review of Logbooks, logcards, Batch records.
• Assisted in the process of Hold time study including sample collection, review of reports.
• Assisted in the validation process of uncoated and coated tablets.
• Assisted in requalification of equipment in the site.

Quality Management system:

• Assisted in Supplier QA activities.
• PQR entries of the batches before its release and assisted in preparation of APQR.
• Generation of COA's through SAP.
• Issuance of Batch records.
• Maintenance and archival of master documents in the site.
• Maintenance and day-to-day upkeep of executed batch records.
• Distribution of SOP's and other cGMP related documents within the site.
• Responsible for Preliminary stage investigation of technical complaints received by the site.
• Induction and GMP training of new recruits into the site.
• Revision of GMP manual to be updated according to the cGMP guidelines.