B Pharma Pharmacist Post Available @ Intas Pharmaceutical Ltd
Pharmacist Post vacant @ Intas. Intas 2019 Jobs, Intas Pharma jobs, Pharmaceutical Science jobs 2019. Intas hiring B Pharma candidates for pharmacist Post. Interested and eligible candidate can Apply for this post. Check out all the details on the Same:
Job Title: Pharmacist – CRO / Pharma
Eligibility:
Bachelor or Master Degree, or equivalent (e.g. Pharm. D.), in biology, pharmacy, or other health-related disciplines, international trade or logistics business.
Relevant work experience/degree.
Position Summary:
Under general supervision of the Head/management level position within the department, we are looking for a reliable Sr. Pharmacist to be responsible for the overall clinical trial storage, production activities (Labeling, Primary and secondary packaging), sourcing and distribution strategy of the clinical trial material in the depot. Sr. Pharmacist ensures under supervision of Head of department that clinical trial studies are progressing and systems are set up and maintained according to quality standards, SOPs and applicable ICH-GxP* and other applicable industry guidelines.
Primary Duties and Responsibilities:
- Fulfill all the legal regulatory requirements, set forth by the Ministry of Health, Maintain and assure compliance with applicable ICH, GMP and Good Clinical Practices, local regulatory affairs, legal Requirements, and Standard Operating Procedures (or any other as required).
- Be familiar with the Protocol or any other related Clinical Trial material.
Ensure that all the activities performed such as reception, storage, production, labeling, Printing, shipment, etc. are in accordance with the SOPs, previously established.
Coordinates and performs key accountability tasks for Clinical Trial Supplies (IMP and Non-IMP), Lab Supplies, Samples and Ancillary Supplies. - Supervise complaint handling following GxP guidelines.
- Responsible of filling BMR / BPR and related documents on day to day basis.
Guidance to the staff on Tablet & Liquid Oral (Primary & Secondary Packing Line.)
Having knowledge of filling up the production related documents and following the procedures as per SOPs (standard operating procedures) Maintaining User, cleaning & maintenance log book of different equipment. - Completion of BMR (Batch Manufacturing Record), equipment log record and all GMP (Good Manufacturing Practice) records.
- Supervises and track manufacturing processes and control GMP compliance.
- Provides input into development of documents including master labels for study medication, manuals and quality documentation.
- Supervise label development and labeling process.
- Leads collection of document and QC on printability and develop print project plan.
- Determines materials specifications and demand according to protocol, establishes the resulting based on materials shelf life.
- Collaborates with procurement to identify and qualify Third Party Supplier vendors, subject to relevant Department Head agreement and Procurement.
- Communicates with 3rd party providers and negotiates scope of work in conjunction with procurement.
- Keep track of quality, quantity, stock levels, delivery times, transport costs and efficiency of the clinical trial supplies(IMP; Lab samples and Ancillary supplies)
- Supervises set-up and maintenance of inventory management systems (e.g. IVRS).
- Supports coordination of purchasing, manufacturing, distribution, return, recall and destruction of clinical trial materials, as applicable.
- Oversee CTM site master file documentation, Supervise, coach and train depot staff.
Skills:
- Ability to communicate effectively in English both orally and in writing
- Strong organizational skills; attention to detail
- Excellent problem solving skills; ability to resolve issues effectively and efficiently
- Strong interpersonal skills; ability to develop and maintain cooperative working relationships with others
- Ability to work independently and to handle a variety of tasks simultaneously
- Knowledge of Microsoft Word, Excel, Outlook and PowerPoint
Salary: INR 2,50,000 – 4,00,000 P.A.
