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Executive, MS&T-CPV
5-7 years
₹ 4.2 - 9.5L/yr (AmbitionBox estimate)
Mumbai, Nagpur, Thane + 3 more
1 vacancy
Executive, MS&T-CPV
Apotex Research
posted 2hr 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.
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- 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.
- 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 5-7 year of experience in the pharmaceutical industry
Employment Type: Full Time, Permanent
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