Company Name: Biocon Limited
Job Description: Senior Manager-quality Assurance
Work experience: 10 – 15 Years
Work location: Bangalore
Education: UG - BSc - Any Specialization, B. Pharma - Pharmacy
PG - MSc - Any Specialization, M. Pharma - Pharmacy
DOCTORATE - Doctorate Not Required
Job Description
Job Responsibility: Quality Planning and scheduling. Involving in all
quality related matters in the site.
1.Budgeting for Quality Assurance Department.
2.Implementation of companies Quality policy and GMP Regulations at
site.
3.Overall monitoring of quality activities in the area of operation.
4.Coordinating with team members for achieving quality requirements.
5.Review of internal GMP rounds report / inspection outcome and review
of action plan.
6.Handling of Customer / Regulatory Audits.
7.Review of audit reports and CAPA response reports.
8.Handling of Vendor audits.
9.Response to regularoty queries and deficiencies.
10.Review of Internal Audit Reports.
11.Review and resolution of customer complaints.
12.Handling of Product Recalls
13.Review and Approval of Out of Specification.
14.Review and Approval of Out of Trends.
15.Investigation of deviation, batch failure, Rejection and final
disposition.
16.Responsibility of batch release.
17.Review and approval of TTDs.
18.Review and Approval of Quality Agreements.
19.Approval of validation /qualification protocols and reports.
20.Approval of Quality Documents which includes SOPs, EOPs, IOPs etc.
21.Approval of Annual product Reports.
22.Training of company personnel in Quality Management Systems.
23.Recruitment of personnel to the QA Department.
24.Responsible to follow the safety and environmental procedures
deployed in the site.
25.Coordinate with central documentation team and Corporate team for
harmonization of SOPs and review of the procedures finalized at Central
documentation team.
Desired Profile
Candidate should have experience in site QA .Should be post graduate with 10-15 years of experience
in quality experience in API with leading pharmaceutical company.
Contact Details: Syngene International Limited, Biocon Park, Plot
2&3, Bommasandra Industrial Estate - Phase-IV, Bommasandra - Jigani Link
Road, Bangalore - 560 099
+91 80 2808 2808 Phone
Email: careers@syngeneintl.com
Website: www.syngeneintl.com