Quality Control Incharge
4 days ago
Job Purpose
To supervise the quality control activities of Lab Operations & ensure compliance as per cGMP, regulatory and QMS requirements for Site F-268.
Quality Control Incharge role is responsible for the requirements in accordance with the Local Regulations.
Education, Experience & Skills
M.Sc. Chemistry or Pharm-D
Minimum 10-years' experience of testing for M.Sc. Chemistry / Pharmacist of having 6 years' experience of testing.
Computer literacy, minimum to access and utilize emails for official correspondence.
Use of MS-Office (Word, Excel, PowerPoint) at least to a moderate level.
Stakeholder management and good communication skills.
Stay updated with the latest local regulatory standards and pharmacopoeia requirements and guidelines related to QC in the pharmaceutical industry.
Ability to work in a fast-paced, highly regulated environment.
Experience leading teams and managing laboratory operations
Key Responsibilities
Oversight for the testing and release / rejection of incoming materials, intermediate, bulk, and finished products, and batch records for site and for contract manufacturing.
Oversee the Quality control processes, including sampling, testing and inspection of raw material, finished Products & Utilities. Oversee specifications, test methods, and other quality control procedures. Ensure analysis is being carried out in compliance with the standards in case of any contract
Perform & review of current standard related to QMS and local regulatory for Quality Control Lab.
Perform and approve appropriate validations pertaining to Lab ops, including those of analytical procedures, cleaning method validation & Equipment validations. Ensure routine cleaning verification on time.
Ensure timely completion of equipment calibrations and ensure DI Compliance
Oversee the maintenance of the department, premises, and equipment.
Oversight that the initial and continuing training of Quality personnel is carried out and adapted according to need Lead self-inspection process for the governance of Quality system in compliance with QMS and Local regulatory requirements.
Responsible for the management and timely updation of legal agreements, quality agreements, and also responsible for third-party risk management.
Ensure timely creation, submission, and approval of purchase orders to facilitate the availability of laboratory consumables and CAPEX items, ensuring uninterrupted laboratory operations.
Provide support to ensure the timely preparation and submission of responses pertaining to laboratory operations for regulatory queries
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Contact information:
You may apply for this position online by selecting the Apply now button.
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