Bayer CropScience Ltd Vapi Job For M.Pharma / B.Pharma
About Company
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. With our innovative products, we are helping find solutions to some of the major challenges of our time. At the same time, the Group aims to create value through innovation, growth and high earning power.
Education & Qualification Details
Education
B.Pharma / M.Pharma
Experience Required : 3 - 6 Years
Vacancies : 02
Job Location : Vapi(Gujarat)
Department : QA Documentation
Job Description
Position Purpose:
To ensure cGMP Compliance (IPQA) and documentation related to GMP Plant.
What to Do:
1.Review and issuance of batch manufacturing records, batch packing records, equipments cleaning records.
2.Control of all Master documents like formats, logbooks, BMR,BPR & other quality related documents.
3.The incumbent will responsible in the shift for quality assurance like verifying executed documents e.g. completed/ ongoing production activities related documents and records. Responsible to ensure that employees working in shift strictly adheres to safety practices.
4.Ensuring SOPâs are strictly adhered during shift activities.
5.Making sure that effective systems are used for maintaining and calibrating critical equipment.
6.One of the key QA team member doing Internal audits(self-inspections) at site and to take follow-up for CAPA completion.
7.Participate in customer and Regulatory authority inspections.
8.Conducting surprise checks to assess SOP vs practices at site.
9.Conducting training sessions of GMP awareness training, SOP training to newly joined employees.
10.He should, under the guidance of GMP QA Head, to review of URS, DQ, IQ, OQ & PQ protocols pertinent to Bulk manufacturing, Engineering, Warehouse, Quality Control and other general areas and ensure that further periodic requalificationas of Area / Equipments are carried out based on schedules.
11.Handling of Deviations Change Controls & CAPAs pertinent to Bulk Manufacturing areas, Quality Control, Engineering, Warehouse and Housekeeping areas. Any other associated reports pertinent to GMP areas, under the guidance of GMP QA Head.
12.Any other work assigned by Site QA lead / Head of the Department.
Who you are:
1. Should have 3 to 6 years of experience in Q.A. of pharmaceutical industry
2. Should be familiar with Local & regulatory (USFDA,MHRA and Eu-GMP) requirements
3. MPharm/B.Pharm with GMP QA documentation experience
4. Should be comfortable to work in shifs