Job Description
Designation: Junior Manager
Job Location: Mangaluru.
Department: Corporate Quality Assurance-Validation
Job Purpose:
- He/she shall be responsible for qualification/validation and re-qualification/revalidation activities of Facility, Utility, Equipment, and System in API facility.
- Review all qualification/ validation related documents, SOPs.
Key Responsibilities:
- Preparation and review of Equipment and Utility qualification relevant procedure and ensuring execution compliance as per approved SOP.
- Responsible for preparation/review/approval of protocols and reports in line with site-specific SOP.
- Review of procedures, URS, impact assessment, Risk assessment, protocols & reports for qualification & validations for facility/Area, equipment & utilities.
- Coordinate qualification/validation activities with the stakeholder departments, ensuring the timely completion of projects and project milestones.
- Ensure QA validation oversight during FAT, commissioning, IQ, OQ, and PQ as per qualification requirements & documentation.
- Review of design documents and execution of IQ, OQ, and PQ activity of the new facility/product/process critical equipment and documentation in place in time as per the defined procedure.
- Review of Computerized system validation deliverables as per procedure and compliance of GAP assessment activities.
- Review of facility, Utility related drawings/layouts (for ex., pressure differential, AHU zoning, area classification, equipment layouts, piping drawings, isometric drawings, etc.).
- Ensure CQA validation oversight during periodic validation of critical utilities such as HVAC systems, water systems, and compressed air systems revalidations.
- Technical evaluation for facility /utility, equipment modifications.
- Review of VMP calendar ensuring execution of periodic qualification/mapping/validation activities as per VMP calendar tolerance.
- Support external client audits and regulatory inspections.
- Any other responsibility as assigned by Reporting Manager Validation based on knowledge, experience, and training.
- Preparation of Technical write-up to comply with audit requirements.
Educational Qualification:
M. Pharm/B. Pharm /M.Sc. /B. Tech with minimum 6 to 9 years of working Experience in API facility Quality Assurance/Validation/External Manufacturing Facility /CRO Function.
Technical/functional Skills:
- Technical knowledge in the Qualification/Validation of API or Formulation facilities is mandatory.
- Preference is given for candidate experience in API along with Formulations and Injectable facility.
- Should have Experienced in Pharmaceutical Validation system.
- Along with Equipment and Utility qualification experience, Work exposure to the process, cleaning validation is preferred.
- Should be knowledgeable on validation guidelines as per different regulatory requirements, e.g., GAMP, ICH Q7, PICS, WHO, ISPE, MHRA, EMA and US FDA guidelines.
- Can establish good Interpersonal skills with cross-functional teams
Experience:
Minimum 6 to 9 years of working Experience in API facility Quality Assurance/Validation/External Manufacturing Facility /CRO Function.
Behavioral Skills:
- Communication.
- Conflict Resolution.
- Self-Improvement.
- Time Management.
- Stress Management.
- Patience.
- Balance Between Professional & Personal Life.
- Empath
Kindly apply through below link or share your resume at Ashitha.Shetty@Syngeneintl.com
