Apotex
Designation : Senior Manager
Function : Quality
Functional Area : Qualifications and Validations
Job Role Summary : To Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging validation and perform the activities in compliance with the various regulatory guidelines and standards. To monitor regular activities related to quality validation and engineering as per established procedures.
Job Profile :
- Review and approval of documents pertaining to equipment/utility qualification, cleaning validation, process validation, hold time studies and packaging validation.
- Approval of layouts, yearly & monthly schedules, to be added planners.
- SME for Qualifications and Validations during Regulatory audits and ensuring compliance to regulatory requirements.
- Assess change controls related facility, equipment, process, utility, cleaning and packaging.
- Review & approve of standard operating procedures.
- Co-ordination and implementation of training activities of team members.
- Responsible for review of site VMP’s (Validation Master Plan) and related documents.
- Responsible for review and approval of process validation & cleaning validation protcolsand reports.
- Co-ordinate with cross functional teams in Investigations carried out at ARPL.
- Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion,
- Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
All other duties as assigned as per the expertise in the relevant subject.
Job Requirements :
- Possess sound knowledge in Qualification and Validation of Equipment, Facility, Utilities, Process and Cleaning
- Maintains good Interpersonal skills and communication skills.
- Strives to drive projects related to Validations & Engineering effectively.
- Experience: Minimum 12 - 15 years of experience in GMP Regulated pharmaceutical industry
Work / Job Experience : 12-15 Years
Type of Experience : Pharma Qualification, Validation - Facility, Equipment, Process, Cleaning Validation
Academic Qualifications :
Minimum Bachelor of Pharmacy/ Science or any equivalent degree.
