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Swiss Parenterals Ltd
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Production - QMS (Executive)

Production - QMS (Executive)

Swiss Parenterals Ltd

3 - 7 years

0 Lacs

gujarat

Posted:1 week ago| Platform: Shine logo

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Skills Required

manufacturing sops qa qc maintenance qms deviations capa change control preventive actions compliance data integrity cgmp regulatory requirements training injectable production batch manufacturing records documentation updates risk assessments good documentation practices gdp sop revisions audit preparation gmp audits parenteral background

Work Mode

On-site

Job Type

Full Time

Job Description

As an Officer to Executive in the Production QMS Department at our company located in Bavla, Ahmedabad, your role will involve the following key responsibilities: - Injectable Production Activities: - Execute and oversee the daily manufacturing of injectable products, whether aseptic or terminal sterilized. - Adhere to batch manufacturing records (BMRs) and standard operating procedures (SOPs) throughout the production process. - Collaborate with QA, QC, and Maintenance teams to ensure seamless operations. - Quality System Support: - Manage QMS tasks including handling deviations, CAPA, change control, and updating documentation. - Participate in investigating and resolving quality events related to production. - Assist in conducting risk assessments and implementing preventive measures. - Compliance & Documentation: - Maintain accurate documentation of all production activities. - Uphold data integrity and good documentation practices (GDP). - Support the revision of SOPs to align with current practices. - Audit Readiness: - Aid in preparing for both internal and external GMP audits (such as USFDA, EU, WHO, etc.). - Ensure adherence to cGMP, regulatory requirements, and internal company standards. - Training & Improvements: - Conduct or attend training sessions on GMP and QMS. - Propose and execute enhancements to enhance process efficiency and quality. You should have exposure in the Parenteral background to excel in this role. If you are interested in joining our organization, please share your detailed Resume with us at Recruitment@swiss.in.,

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Production - QMS (Executive)