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Pfizer
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Associate Manager - MSAT Validation

Associate Manager - MSAT Validation

Pfizer

5 - 10 years

0 Lacs

andhra pradesh

Posted:16 hours ago| Platform: Shine logo

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Skills Required

validation quality assurance quality control gmp change control data analysis project management communication skills pharmaceutical manufacturing packaging autoclave instrument calibration fda regulatory guidelines failure investigations validation master plan quality review vial washing depyrogenation tunnel homogenizers vial filling filter integrity testing visual inspection equipment packing equipment cleaning validations

Work Mode

On-site

Job Type

Full Time

Job Description

As a member of Pfizer's quality assurance team, you will play a crucial role in ensuring the delivery of safe and effective products to patients. Your commitment to quality, compliance, and patient-centric approach will directly impact the lives of those who rely on our products. Your responsibilities will include evaluating and reviewing clinical and commercial drug batches to ensure they meet established specifications. You will conduct rigorous sampling and statistical process control procedures to identify deviations from standards and approve investigations and change control activities to maintain compliance with configuration management policies. In this role, you will contribute to moderately complex projects by managing your time effectively and developing short-term work plans. Your ability to independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts will be crucial in maintaining regulatory compliance. Your preferred educational background should include a degree in B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/ BE and 5-10 years of experience in the validation function of a sterile injectable dosage form facility. Your core competencies should include familiarity with the design and working principles of key equipment used in sterile manufacturing, knowledge of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations, and expertise in validation principles and practices related to various areas. You should be well-versed in Terminal process design, execution, and review, as well as experienced in plant and TS operations. Your document review skills, data analysis capabilities, and knowledge of validation instruments and tools will be essential in this role. You should also have a good understanding of current validation regulations, cGMPs, FDA regulatory guidelines, and other industry standards. Your technical skills, leadership abilities, organizational planning, and project management capabilities will be put to the test as you coordinate multi-disciplinary teams and ensure compliance with global regulatory and Pfizer quality standards. Strong interpersonal and communication skills are also required to interface across departments and management levels effectively. If you are looking to use your expertise for a purpose-driven role, Pfizer is an equal opportunity employer that values diversity and compliance with all applicable equal employment opportunity legislation. Your work location will be on-premise, where you will have the opportunity to make a meaningful impact on patient outcomes through your commitment to quality assurance and control.,

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Pharmaceutical Manufacturing

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Associate Manager - MSAT Validation