Department: Quality Control For QMS Investigator
Position: Executive / Sr. Executive
Key Accountabilities / Responsibilities:
1. To raise QMS related documents like, Deviation, Out of specification, Out of trend results observed.
2. Prepare the Investigation report along with QA representative and execution immediately.
3. Prepare the summary report and trend of QMS data.
4. Ensure that, closing of Deviation within time frame as well as CAPA closer within predefined Targeted date (TCD).
5. To follow Good laboratory practices (GLP), Good documentation practices (GDP) and safety precautions during routine analytical activities.
6. Ensuring good relations and communications with all members of the team and responding politely and in a timely manner to internal and external customers.
7. Working with all members of staff to maintain and develop the positive progressive culture within the laboratory.
8. Any other additional responsibility given by Section In-charge.
9. Candidates should also have sound knowledge of cGMP documentation and must be familiar with cGMP requirements.
Department: International Business Development
Position: Executive/Sr. Executive
Key Accountabilities/ Responsibilities:
1. Potential client identification & business collaboration
Identify the potential client by analyzing IMS/ export-import (EXIM) data / social networking sites for assigned territory of European countries along with point of contact.
Preparing customer profile for senior leadership approval before contacting customers
Share corporate presentation via e-mails, telecons to customer to promote CMO / CDMO / OL business models and collect forecasts for interested products
Follow up on new projects with existing customers along with internal confirmation on IPR & RA aspects
Prepare costing required sheet and collect / evaluate commercial proposal for sharing with customer
Follow up & negotiate on commercial proposal, agreement drafts in co-ordination with legal team
Preparing DRF and arrange dossier audit as per customer requirement for due diligence in co-ordination with RA team.
2. CMO
Hosting telecons with both internal & external stake holders to facilitate the discussion on gap analysis / challenges.
Coordinate with internal stake holders for timely completion of feasibility trails, validation batches and commercial batches.
3. CDMO/out-licensing
Arrange the product-wise SOW (Scope of Work) which majorly includes milestones payment, product forecast & associated development cost.
Tracking of projects & arranging stake holders feedback / approval where-ever necessary
Follow up internally for additional cost incurred & negotiating with customer for absorbing the same
Creating milestone / pass thru cost invoices, sharing with customers & follow up on payments.
4. Market intelligence and data analysis
Understanding competitors and business trend in market for Unison portfolio by analyzing IMS / EXIM
Evaluating potential business from new products (Oral solutions & Capsules) using IMS data.
5. Backend activities
Order Management
PO acknowledgement to customer; check batch size & COGS in line with agreement
Cross-check with finance for profitable COGS in current scenario.
EOC drafting & initiation
Gather comments from RA /PD /QA for MA, variation approval, artworks, FG codes
Sharing updated EOC across internal stake holders for review & signing
Follow up with Purchase, PPMC & Production for OTIF delivery.
Customer relationship management with real time updates & telecons on challenges
Follow up with customer on pick up of goods and payment receipt against open invoices.
6. MIS activities
Maintain masters for Orders and License Fee / Pass thru costs
Compiling EOCs, Tracking open invoices, payment due dates & receipts
MPRM report preparation
SnOP report preparation
Weekly BD report on lead generation status.
7. SAP activities
Business partner creation
Goods & Service order Booking / Reversal / Cancellation
Service Invoice / credit note issuance & printing
Follow up internally on FG / SFG code creation in SAP
Validation of new functions in Development / Quality server.
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