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