We are hiring Associate - AS&T for MNC Pharma company in Baddi

Job Description:

• Designation: Associate - AS&T
• Location: Baddi
• Qualification: Any
• Working days: 
• Working time: 
• Experience: 10+ Years
• Salary: Best in industry

Note: This role will be on payroll of Talisman HR Solutions

Job Profile:

Support Established Products Operations (EPO) technical functions- India region for India market.

 Job Responsibilities:

1. Review the technical dossiers for availability of required documents against approved checklist for all new products and source change products.
2. Review of dossier documents (Analytical related) for its correctness.
3. Review of specifications (RM/PM/FG) against Pharmacopoeia requirements as well as provide technical support in compendial compliance in existing products.
4. Review of vendor & IH COAs against specifications and provide technical support to Alternate vendor development activities.
5. Prepare synopsis of observations/gaps pertaining to individual product dossier and effectively communicate with Third Party Manufacturers (TPM) to mitigate the gaps.
6.  To Support shelf-life extensions by reviewing the available stability data for API & FG using suitable statistical tools.
7. To support Analytical method transfer of identified products through protocol design, execution supervision, raw data review and report approval.
8. To provide technical support to third party manufacturer for new product introductions from analytical prospective.
9. To provide technical support to prepare Analytical method validation Protocol & Reports and overview the activities, as per requirements.

Qualifications:

1. MSc - Preferably in Analytical Chemistry or M. Pharm in Analytical Chemistry / equivalent.
2. Have experience of at least 10 years as team lead/ Assistant Manager in QC / Analytical development dept.
3. Should have experience in analytical testing for API’s and excipients including preparation of specifications and STP for same.
4. Hand-on experience in testing / method development / Validation / method transfer of oral solid & liquid dosage forms. Experience in handling Injectables & semi-solid dosage forms will be an added advantage.
5. Experience in handling various analytical Instruments such as HPLC, GC, UV, FTIR and Dissolution apparatus, including other routinely used instruments in analytical lab.
6. Have knowledge of drafting specifications and analytical procedures for various dosage forms
7. Have basic computer skills & expetise in writing technical documents.