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