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Lead Executive - MS&TCPV
8-10 years
₹ 8.65 - 13.61L/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.
Mumbai
1 vacancy
Lead Executive - MS&TCPV
Apotex Research
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Responsible for preparation and coordination of Process Validation-Stage 3 (CPV) studies, in accordance with FDA, HPFBI, EC, and ICH s guidelines and applicable Apotex policies and processes.
Job Responsibilities
- Creates protocol/reports and other documentation related to CPV Stage 3B, in PACE and other systems.
- Collects data from SAP and LIMS and other quality system to compile reports, performs statistical analysis and evaluations, as required and ensures that CPV reports follows Apotex procedures and policies.
- Creates and reviews projects in PACE and ensures completion of all actions in PACE (e.g. validation history, batch planning), as applicable.
- Monitors and assesses Stage 3B trending of products as required.
- Coordinates and executes all related activities with cross-functional teams for timely escalation and closure of reports.
- Supports CPV management in achieving departmental goals.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensures personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, policies and procedures, Safety and Environment policies, and HR policies.
- Works with the Supervisor, assists in coordinating the training of new employees.
All other relevant duties as assigned
Job Requirements
- Education
- Degree, Diploma or Certification in Chemistry, Pharmaceutical Technology, Pharmacy or related science
- Knowledge, Skills and Abilities:
- Proven organizational, problem solving, and project and time management skills demonstrated by previous work experience, in order to manage multiple priorities in a fast-paced environment.
- High level of familiarity with Excel, Word, PowerPoint and statistical tools required.
- Excellent English oral and written communication skills.
- Knowledge of validation concepts and regulatory guidances (e.g. PV guidance, ICH 8, 9, 10, 12) is an asset
- Ability to be flexible and multi-task in a rapidly changing environment.
- Experience
- Minimum 8-10year of experience in the 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 18 Apotex Research interviews)
Referral
Company Website
Recruitment Consultant
Campus Placement
Walkin
Job Portal
11%
11%
11%
6%
6%
6%
49% 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 people at Apotex Research are saying
Rating based on 8 Lead Executive
reviews
Anonymous · Legal & Regulatory - Other
in Mumbai
Likes
Office at godrej
Dislikes
No support to employees from HR or heads or even Mumbai office head.
Read 8 reviewsLead Executive salary at Apotex Research
reported by
84
employees
with 6-14
years exp.
₹7
L/yr - ₹14
L/yr
46%
more
than the average Lead Executive Salary in India
View more details
What Apotex Research employees are saying about work life
based on 768 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Apotex Research Benefits
View more benefits
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