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1 Aurigene Pharmaceutical Services Team Member Job
Team Member - DQA
5-10 years
Hyderabad / Secunderabad
1 vacancy
Team Member - DQA
Aurigene Pharmaceutical Services
posted 5mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Qualification: Masters
Must have skills:
- Must have Experience in Quality Assurance with API R&D / NCE CDMO labs facility.
- Previous stint in analytical development for NCE / API will be added advantage.
- To ensure Compliance with Corporate Policies (Quality, Safety, COBE etc)
- To ensure respective Standard Operating Procedures to be followe'd during the development of the molecules.
- Preparation, review, approval, control and revision of standard operating procedures.
- Preparation, review, approval, control and revision of Site Mater File, Quality agreements.
- Documentation control (Issuance, Retrieval, Supersede, Obsolete and Destruction)
- Investigation, Implementation, Approval and Compliance of Quality Systems (Change Controls, Incidents, OOS and CAPA)
- Coordinate with the plant team to investigate complaints, stability OOS, and manufacturing incidents.
- Review and Approval of Calibration and Preventive Maintenance Schedule and to ensure the activity carried out as per the schedule
- Review and Approval of Qualification Protocols and Reports (Facility, Utility, Equipment,)
- Review of Experiments in Electronic Lab Notebook (ELN)
- Review, Approval and distribution of Analytical Method Validation protocols, Reports, Specification & Method of analysis, cleaning validations, Method summary reports etc,
- To perform Quality Risk Assessment and QbD as per Customer Requirement
- Supporting regulatory affairs team for ANDA/NDA filling and regulatory deficiency closure
- Planning and Execution of activities related to Development Quality Assurance.
- Qualification and Compliance of External Manufacturing Facilities (SBP).
- Participate in Customer Teleconferences and respond to the Customer queries.
- Review presentations and presenting quality issues through Quality Management Review.
- Review, approval, distribution of development documents like Feasibility report, Optimization report, Familiarization report, FMEA report, QBD report.
- Allot the project code for the new project, allot technical numbers & document numbers to AR&D and R&D.
- Conduct gate meeting and facilitate the technology transfer between development and absorption team.
- Handling of technology transfer queries and arranging technology transfer documents by coordinating with the concerned departments.
- Review of Master Batch Production records, change notifications received from SBP s and approve, issue in timely manner.
- Tracking of customer audit reports and responses.
- Any other responsibilities assigned by the group leader/head of the department
Employment Type: Full Time, Permanent
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People are getting interviews at Aurigene Pharmaceutical Services through
People are getting interviews through
(based on 16 Aurigene Pharmaceutical Services interviews)
Referral
Campus Placement
Walkin
Job Portal
37%
19%
19%
19%
6% candidates got the interview through other sources.
High
Confidence
?
High Confidence means the data is based on a large number of responses received from the candidates.
What Team Member
at Aurigene Pharmaceutical Services are saying
Rating based on 5 Team Member
reviews
Anonymous · Engineering
in Hyderabad
Likes
Culture
Dislikes
Inefficient and lazy maintenance team.
Read 5 reviewsTeam Member salary at Aurigene Pharmaceutical Services
reported by
20
employees
with 1-12
years exp.
₹3.2
L/yr - ₹12
L/yr
75%
more
than the average Team Member
Salary in India
View more details
What Aurigene Pharmaceutical Services employees are saying about work life
based on 197 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Aurigene Pharmaceutical Services Benefits
View more benefits
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Aurigene Pharmaceutical Services Hyderabad / Secunderabad Office Location
Hyderabad / Secunderabad, Telangana Office
Bollaram Road, Miyapur,
Jaya Prakash Narayan Nagar, Miyapur.
Telangana 500049
India
Hyderabad / Secunderabad, Telangana
500049
500049
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