Equipment QualificationValidation Team member
Equipment QualificationValidation Team member
Posted on :
20-01-2025
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Job Description
Job Title: Equipment Qualification/Validation Team member
Job Location: Mangaluru Karnataka India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Title: Equipment Qualification/Validation Team member
Date: 12 Dec 2024
Job Location: Mangalore
Pay Grade
Year of Experience:
Designation: Senior Executive
Job Location: Mangalore
Department: Corporate Quality Assurance
About Syngene
Incorporated in 1993 Syngene International Ltd. is an innovationfocused 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 BristolMyers 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 Description
Key Responsibilities:
Technical/functional Skills
Behavioural Skills
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.
Date: 12 Dec 2024
Job Location: Mangalore
Pay Grade
Year of Experience:
Designation: Senior Executive
Job Location: Mangalore
Department: Corporate Quality Assurance
About Syngene
Incorporated in 1993 Syngene International Ltd. is an innovationfocused 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 BristolMyers 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 Description
Key Responsibilities:
- Preparation and review of equipment utility qualification relevant procedure and ensuring execution compliance as per approved SOP.
- Responsible for preparation of protocols and reports inline to site specific SOP for chemical development facility.
- Review of procedures URS impact assessment Risk assessment protocols & reports for qualification & validations for facility/Area equipment & utilities in facilities.
- Coordinate the activities of qualification/validation with the stakeholder departments ensuring the timely completion of projects and project milestones.
- Ensure QA validation oversight during FAT commissioning /SAT and IQ OQ & 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 along with documentation in place in time as per defined procedure.
- Review of facility Utility related drawings/layouts (for ex. pressure differential AHU zoning area classification equipment layouts piping drawings isometric drawings etc.).
- Ensure QA validation oversight during periodic validation of critical process equipment utilities such as HVAC systems water system and compressed air systems revalidations.
- Supporting to prepare VMP Calendar. Ensuring execution of Requalification activities as per VMP calendar tolerance.
- Support external client audits and regulatory inspections.
Technical/functional Skills
- Technical knowledge in chemical API is must.
- Technical knowledge in Biologics and Injectable are add on value.
- Should have minimum 3 years of work experience in Pharmaceutical Validation systems (Facilities Utilities Equipment and Computerized Systems).
- Manufacturing Computerized System Validation (CSV)/ Process Control System deliverable preparation/review.
- QMS procedures.
- Should be knowledgeable on validation guidelines per different regulatory requirements and Industrial bodies e.g. ICHQ2 ICH Q7 WHO US FDA EU guidelines 21 CFR ISPE PDA and PICS.
- Interpersonal skills to establish collaboration with crossfunctional teams
- Establish good Interpersonal skills with crossfunctional teams.
Behavioural Skills
- Should have good communication skill and should be a good team player.
- Ability to work successfully in a dynamic ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
- Excellent written and verbal communication skills
- Good interpersonal skills
- Analytical strengths and high trouble shooting ability
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.
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Employment Type
Full Time
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