Fresher

Conduct in-process and retrospective audits for studies and method validations. Review reports, source data, audit trails and regulatory compliance. 

Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met with minimal supervision.

Shodhana Laboratories is a pharmaceutical company specializing in Active Pharmaceutical Ingredients (APIs) and Intermediates. Established in 2000, they cater to both generic and custom requirements for well-known pharmaceutical brands.

Basic knowledge of medical terminologies and able to understand common medical terms relevant to pharmacovigilance and adverse event reporting. Elanco Animal Health

You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments

Review QMS documents, SOPs, processes and records for compliance with GMP requirements; Support OOS, OOT, deviations, change controls, CAPA, risk assessments and investigations; Ensure compliance with ALCOA+ data integrity principles

Candidates who are Physically fit, responsible, willing to work in a manufacturing/pharmaceutical environment are encouraged to apply.

Knowledge about troubleshooting and experience in handling FETTE & SEJONG compression machines. Required exposure in regulatory audits. 

Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy.