A very well known pharma formulation company
Summary
Experience: 11 - 20 Years
Compensation: Negotiable of Current CTC
Education: UG - B.Pharma - Pharmacy PG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production, Maintenance, Quality
Desired Candidate Profile
1.Experience in handling ophthalmic / liquid injection/ svp / nasal spray etc
2.Preparation and execution of validation protocol and activity – Steam sterilizer , Tunnel, Filling machine, Vial washing, HVAC, water system.
3.Operation and trouble shooting of Injectable equipments –like Filling machine, Tunnel, vial washing, Autoclave, Labeling machine.
4.Preparation and implementation of defined SOP’s and GMP guideline.
5.Execution of Process validation, cleaning validation activities.
6.Preparation of SAT, DQ, IQ, OQ, SOP
7.Internal audits and deviations.
8.Documentation and experience to face regulatory audits like USFDA, MHRA, TGA etc
Job Description
1. Knowledge of concepts of Good Manufacturing Practices (GMP) as well as Good Documentation Practice (GDP).
2. Effectively handling of all Validation activity in sterile Manufacturing.
3. Efficient in handling of Regulatory Audits and internal Audits.
4. Expertise in investigation of customer complaint & in time feedback to concerns.
5. Well versed with quality production system in manufacturing area through various in process Checks, line clearances and SOP's for quality production.
6. Checking and submission of Exhibit batch records for ANDA
7. Audit Preparation and facing Auditors for the responsibility given.
8. Excellent documentation skills and inter-personal skills.
Keywords: SVP, Vial, Sterile, Eye Drops,Nasal line ,PFS line , approved chemist
Company Profile
A very well known pharma formulation company
Contact Details
Company Name: A very well known pharma formulation company
Executive Name: Anil ummatt/ Surbhi
Address: HRServices
HR SERVICES, SCO 81,2nd Floor, Swastik Vihar
MDC,Sector 5 Panchkula
CHANDIGARH,Chandigarh,India 160001
Reference ID: Head sterile prod