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Biological E

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20 Biological E Jobs

AGM/Sr.Manager

14-20 years

Hyderabad / Secunderabad

1 vacancy

AGM/Sr.Manager

Biological E

posted 1d ago

Job Role Insights

Flexible timing

Job Description

Corporate Quality:


  • To Lead the Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across R&D, API and Formulation units of Biological E, pharma divisions.
  • To participate in an On-site audits as part of vendor audits, contract testing laboratories, contract manufacturing and external service vendors qualifications.
  • To approve all Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across API and Formulation units of Biological E, pharma divisions.
  • To Review and approve of Quality Management Systems (QMS), including Change controls, Deviations, Investigation reports and CAPAs.
  • To review and approve Risk assessments related to Vendor, Contract Testing Laboratories and Contract Manufacturing and Service Provider qualification related activities.
  • To approval of Quality agreements & Technical agreements.
  • To provide remediation plans for the audit observations, if any
  • To provide support / relevant information to the customers / suppliers as per the requirement.
  • To Lead the self-inspection audits including schedule, participation in the self-inspections and approve the Self-Inspection reports/ relevant documents as applicable.
  • To review the performance of quality system through review of QMS documents and present the data during site Management Review Meeting.
  • To coordinate and support Site quality management during audits by consultants, external audits, regulatory audits etc.
  • To participate in the Customer and Regulatory audits as per the requirements.
  • Impart the training sessions to the concerned personnel on cGMP, compliance, regulatory updates and to improve awareness at operator or analyst level.
  • To review and assess the effectiveness of system changes and adequacy of CAPAs and post closure effectiveness checks.
  • To review and assess the Health authorities observations at the Site and R&D and verify the compliance.
  • To coordinate with the team for approval of SOPs pertaining to quality system design and associated controls.
  • To Train and qualify the Quality Auditors on Auditing Skills.



Employment Type: Full Time, Permanent

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What people at Biological E are saying

4.5
 Rating based on 44 Manager reviews

Likes

Biological E Ltd. is a reputable vaccine company with an impressive product portfolio, particularly in vaccines that contribute to public health globally. The company is known for its strong R&D and innovation in vaccine development, making it a trusted name in the pharmaceutical industry. The working environment at Biological E is..Read More

  • Salary - Good
  • +6 more
Dislikes

Biological E Ltd. is a well-known vaccine company, but its internal policies leave much to be desired. There is a significant delay in the appraisal process, which affects employee morale and growth. While the company does contribute to public health, the lack of timely recognition and rewards for hard work makes it challenging for e..Read More

Read 44 Manager reviews

Manager salary at Biological E

reported by 143 employees with 13-18 years exp.
₹9.7 L/yr - ₹20 L/yr
11% less than the average Manager Salary in India
View more details

What Biological E employees are saying about work life

based on 1.5k employees
63%
30%
45%
96%
Flexible timing
Alternate Saturday off
No travel
Day Shift
View more insights

Biological E Benefits

Free Transport
Health Insurance
Job Training
Team Outings
Cafeteria
Child care +6 more
View more benefits

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