Troikaa is a young and fast growing system oriented pharmaceutical company. Troikaa is recognized as a discovery company, manufacturing innovative products based on varied Novel Drug Delivery Systems. The company has developed through in-house R&D, unique patented technology platforms for intra-oral, parenteral, sustained release and topical drug delivery. All these innovations are backed by requisite clinical trials. The company has two state of the art manufacturing facilities in India. The plants are designed for approvals in regulated markets. The company has a near zero product failure record. Plants are equipped to manufacture tablets, capsules, liquicaps, parenterals (including parenteral emulsions), topical and inhalation anesthetic products. We have marketing networks in India, South East Asia, Latin America & Africa. Company intends to enter the highly regulated markets by year 2009.
Troikaa Pharmaceuticals Hiiring
Job Vacancy Details:
- Department: Production QMS (Parenteral)
- Qualification: B. Pharm, M. Pharm, MS / M. Sc
- Experience: With 4-9 years of experience
- Job Location: Sanand,Gujarat, Ahmedabad,Gujarat
- Salary: 3.5-7.5 Lacs P.A.
- No.of Openings: 01
- Designation: Executive
Job description
1. Preparation and review of Master Formula Records (MFRs).
a. Preparation & review of MFRs e.g. MCM (Master Card of Manufacturing) and MCP (Master card of Packing).
2. Preparation Batch Manufacturing Record and Batch Packing Record.
a. Preparation & review of Batch records e.g. BMR (Batch Manufacturing Record) and BPR (Batch Packing Record).
b. Review & submission of BMR and BPR along with Batch Record Checklists.
3. Preparation, review and training of SOP related to parenteral department.
a. Preparation and review of relevant SOPs related to parenteral department.
b. Handling of hard, soft copy and scan copy of SOPs, Batch records, etc. (But not limited to) for parenteral department.
4. Good Documentation Practice including preparation of documents as well as records.
5. Issuance of equipment/instrument ID.
6. Responsible to provide training to new joince or existing employees related to OP. BMR, BPR or other documents.
7. Training a Documentation:
a. To complete the training within timeline. To follow GDP while doing documentation work
b. To filled the online documentation (BMR/BPR, Logbooks or other GMP documents) during routine activity.
c. To prepare the SOP, BMR/BPR, protocols and documents related to the production parenteral facility
d. To prepare Study Protocols, study reports and other as and when required. To support the concern department for validation/qualification activity.
e. To initiate and perform the QMS activity like deviation, change control, CAPA, etc.
8. To perform/involved in the area and equipment qualification (1Q, OQ & PQ) and requalification activity as per the respective protocol and documents.
9. To operate SAP transaction as per SOP
10. To ensure safety during execution of project and production related activities.
11. Any other work assign by area supervisors or HOD.
Preferred candidate profile :
Candidates who have handeled deviation and Investigation are highly preferred.
Education Qualification: B.Pharm / M.Pharm / M.Sc
Total Exeperience: Min 4 years of experience in Production along with QMS Profile (Min. 2 years in Production QMS Profile)
Interested candidates can share their resume on [email protected]
