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Senior Executive, Eng&Mnt-QMS
8-9 years
₹ 6.07 - 11.2L/yr (AmbitionBox estimate)
This is an estimate of the average salary range for this
position. It has not been reviewed by the company, and
the actual salary may differ.
Bangalore / Bengaluru
1 vacancy
Senior Executive, Eng&Mnt-QMS
Apotex Research
posted 2mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Responsible for Compliance, QMS activities such as Deviation investigations, CAPA Effectiveness checks, temporary changes, SOP Format preparation, Implementation of GSOPs, Change Controls, Training, Risk Assessments, Gap assessments and Audit related activities. Support for engineering new projects, training management and other activities as assigned.
Job Responsibilities
- Execute all engineering operation as per established ARPL standards and procedures.
- Ensure and maintain safe work place at ARPL all time in coordination with EHS personnel.
- Perform all work in accordance with established regulatory, compliance and safety requirements.
- Initiation and handling of Deviations, CAPA, Effectiveness checks, Non-CAPA follow up tasks, SME records, temporary changes and Change Controls.
- Perform quality investigation with right first time.
- Follow up with the respective cross functional teams for on time completion of deviations/CCR/CAPA/QMS activities.
- Coordinate for audits and preparation of audits responses.
- Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements.
- Execute with Quality Assurance department for preparation and implementation of engineering department SOPs/Formats and other engineering documents.
- Preparation and review of SOP s relevant to engineering including its periodic revision, compliance and trainings.
- Initiation, assessment and closure of change controls related to engineering.
- Conduct impact analysis of proposed corrective preventative actions. Discusses findings with impacted departments and prepare recommendations to implement.
- Assists in quality Investigations Initiations, and CAPA s associated to engineering.
- Support for GMP/Regulatory audit and preparation of audit compliance report ensure closure of audit observations.
- Preparation and review of risk assessments.
- Review of all engineering documents such as protocols, Maintenance work order / notification, calibration report (But not limited to).
- Preparation of Gap assessments for assessing the engineering practices with the procedures.
- Attend training session related to cGMP, regulatory latest technical and industrial developments related to engineering projects.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Job Requirements
- Education
- Minimum Bachelor s degree in Engineering
- Knowledge, Skills and Abilities
- Good knowledge of Quality Management system, exposure to audits, Risk Assessment, etc.,
- Should have good interpersonal and communicational skills.
- Works effectively towards achieving the engineering compliance.
- Hands on experience in Track wise application, SAP and MS Office etc.,
- Shall have exposure to any of the regulatory audits like USFDA, MHRA, TGA HC.
- Experience
- Minimum 8 years of experience in a Pharmaceutical industry
Employment Type: Full Time, Permanent
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People are getting interviews at Apotex Research through
People are getting interviews through
(based on 17 Apotex Research interviews)
Referral
Recruitment Consultant
Campus Placement
Company Website
Walkin
Job Portal
12%
12%
6%
6%
6%
6%
52% candidates got the interview through other sources.
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Confidence
?
High Confidence means the data is based on a large number of responses received from the candidates.
What people at Apotex Research are saying
Rating based on 19 Senior Executive
reviews
Anonymous · Quality Assurance
in Bangalore / Bengaluru
Likes
Good work culture
Dislikes
Everything good only
Read 19 reviewsSenior Executive salary at Apotex Research
reported by
112
employees
with 8-15
years exp.
₹6.1
L/yr - ₹14.5
L/yr
81%
more
than the average Senior Executive Salary in India
View more details
What Apotex Research employees are saying about work life
based on 762 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Apotex Research Benefits
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