key responsibilities and duties of the job include:
• regulatory support and documents preparation as per requirements.
- verification and endorsement of certification of analysis
- verification and endorsement of method of analysis
- long term and short term stability studies of products etc...
• preparation of dossiers as per destination country.
- product standardization for new product development
- product composition/formula approval/artwork approval
- product labelling requirements as per icmr or other guidelines etc...
• gathering, evaluating, organising, managing and collating information in a variety of formats
• communication regarding inquiries with foreign and domestic clients.
• presentation of company and products to foreign clients when requires.
• ensuring compliance with all the regulations set by the medicines and healthcare products regulatory agency (mhra) or health department requirements of destination/particular country.
• maintaining familiarity with company product ranges.
• keeping up to date with changes in regulatory legislation and guidelines.
• analysing complicated information, including trial data of products if requires.
• offering advice about company policies, practices and systems to subordinates or managements.
• liaising and negotiating with regulatory authorities or foreign clients.
• writing comprehensible, user-friendly, clear product information leaflets and labels.
• ensuring that quality standards are met and submissions meet strict deadlines.
• coordination with other departments of organisation whenever requires.
Experience
2 - 4 Years
No. of Openings
2
Education
B.Pharma, B.Sc, M.Pharma, M.Sc
Role
QA Executive
Industry Type
Pharma / BioTech / Clinical Research
Gender
[ Male / Female ]
Job Country
India
Type of Job
Full Time
Work Location Type
Work from Office