Sr Quality Assurance (QA) Specialist - Analytical QA 8-10 Yrs, 40-60LPA 3CCPLA/SQA.ANACHEMI810Y5580K$/111042

[NonIT HR Project]

Dear Consultant,

Urgent hiring Sr Quality Assurance (QA) Specialist - Analytical QA 8-10 Yrs, 40-60LPA 

3CCPLA/SQA.ANACHEMI810Y5580K$/111042

SOURCING GUIDELINES

Must have a strong background in QC/analytical lab and manufacturing.

No employment sponsorship. 

Immediate availability is preferred. 

Urgent need to fill this position.

1.Please DO NOT disclose salary details of the job role to the candidate over email or via social media.

a.You may indicate salary being offered is as per industry standard

2.Please DO NOT post the job on any public forum.

3.Please DO NOT check for Candidates Current compensation as it is against the law. However you can ask for their Salary expectation.

4.ONLY US citizens/ Green Card holders will be processed.

5. NO POACH with Torrent Pharma.

Please replace the first paragraph of the job description with the below content. Thanks.

GENERAL POSITION OVERVIEW

 

The Quality Assurance (QA) Senior Specialist position is an individual contributor role and reports to the Senior Manager of Analytical QA for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary (also known as Cipla New York). THIS POSITION REQUIRES A STRONG ANALYTICAL CHEMISTRY/LAB BACKGROUND AND EXPERIENCE.

The job duties for this position include but are not limited to the following:

Confirming and ensuring the compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.

Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure.

Verifying the standard operating procedures (SOPs) and test procedures.

Verifying process validation and characterization-related documents.

Coordinating with the Regulatory Affairs (RA) and Analytical Laboratory Teams to arrange required documents for timely submission as part of new and existing abbreviated new drug applications (ANDAs).

Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.

Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor for necessary improvements in the identified areas.

Actively participating in laboratory investigations and incidents as well as ensuring the proper compliance.

Evaluating and confirming the compliance related to raw materials, in process and finished product analytical documents.

Conducting random internal audits in analytical lab and ensuring the compliance.

Assessing and implementing of Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.

Performing other departmental and cross-functional projects and assignments given by the manager.

 PROFESSINAL COMPETENCIES AND TECHNICAL SKILLS

Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting.

Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally.

Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.

Must be able to work under minimal supervision and able to work independently and in a team environment.

Must be able to exercise appropriate professional judgment on matters of significance.

EDUCATION AND EXPERIENCE

Possess a bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution.  Master’s degree in the above and/or related fields of study as noted above preferred.

A minimum of eight (8) years of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.

Experience using statistical software packages is a plus.

Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.

Current, working knowledge of quality assurance (QA).

Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc.

 OTHER JOB INFORMATION

 Relocation negotiable.

No employment sponsorship.

No remote work available.

Must be willing to work some weekends based on a relevant business need, if required.

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Shekhar

080-50626011