Required for Junior manager

Job Description

• Designation: Junior Manager Job Location: Bangalore Department: Corporate Quality Assurance-Validation About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.
• Job Purpose:
• Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Experience: Minimum 6 to 9 years of working Experience in Biopharmaceuticals 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
• Educational Qualification: M. Pharm/B. Pharm /M.Sc. /B. Tech with minimum 6 to 9 years of working Experience in Biopharmaceuticals facility Quality Assurance/Validation/External Manufacturing Facility /CRO Function. Technical/functional Skills:
• Technical knowledge in the Qualification/Validation of biologics facilities is mandatory.
• Preference is given for candidate experience in biologics
• 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
• 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 Biologics relevant Autoclave, upstream and downstream equipment qualification, and validation documents
• 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.
• He/she shall be responsible for qualification/validation and re-qualification/revalidation activities of Facility, Utility, Equipment, and System in Biopharmaceuticals manufacturing facility.
• Review all qualification/ validation related documents, SOPs.
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Keyskills :
safetysapmechanicalequal employment opportunitycommissioningtroubleshooting