Merck KGaA

Quality Control Specialist

Posted On

July 22, 2024

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

full-time

Apply By

Jan. 28, 2025

Job Description

Key Responsibilities: Identifying, Planning and Implementation of QC Testing Laboratory in a cGMP Environment, including cleanroom.Experienced in QC lab test methods like Endotoxin (LAL), flow/delta p, and oxidizable substances testing.Proven ability to identify required equipment, interact with stakeholders for procuring, installation, commissioning, IQ, OQ, PQ of Lab Equipment, within the project timelines.Preparataion of all equipment and test method procedures and periodic revisions.Handling of out of specifications and QMS tools to release batch on timeConversant with environmental monitoring in clean room.Conversant with Risk management techniques.Conversant with Microbiology practices.Manage shelf-life studies.Ensuring the laboratory's Quality Management Systems (QMS) conforms with requirements in the ISO 9001 standard, applicable company policies and procedures, and laboratory Quality documents, Developing quality objectives that are compatible with the context and strategic direction of the organization, and for communicating these quality objectives as well as the Quality Policy to all within the organizationProactively identifying risks and opportunities through a variety of surveillance activities including trending of non-conformance events, lab walkthroughs, self-inspections and lab records/data review ensure continued suitability, adequacy, effectiveness and alignment of the QMS with the strategic direction of the organizationEnsure safety aspects, establish cGMP and 6s practise in Prefilter quality lab.Communicating and reviewing risks with site and global management to ensure customer, statutory and regulatory requirements are determined, understood and consistently metStaying current with standards and procedures, applicable industry regulations and trendsBe a global team player willing to embrace multi-cultural, multi-lingual and multi-time zone work environment.Have excellent networking skills allowing effective interactions and the ability to work collaboratively across all functions with various levels of stakeholders.Have proven experience with various problem-solving methodologies.Have demonstrated ability to manage change and implement improvement solutions across cross- functional teams.Ensure ability to manage change and implement improvement solutions across cross-functional teams.Education:Master of Science (Microbiology), Bio technology from reputed college. Work Experience: Must have around 5 years experience and at least 3 years worked in Quality Control laboratory in planning, procuring of lab equipment/consumables and running of QC Lab.Worked in reputed Pharma Industries or research institute preferably good MNC’s.Personal Attricutes: Customer focused, strong communication skills.Proactive and decisive personality.Team player.Flexible .Adaptable, Agile/Responsive, Proactive/Action-Oriented.

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