Ra / QA - Executive (Api - Pharmaceuticals

5 days ago

Mumbai, India Modern group PVT LTD Full time

**Job description**
- To prepare documents for local regulatory submission.
- To review batch manufacturing records protocols and reports of all Active Pharmaceuticals Ingredients and Intermediates to support DMF / FILING.
- To prepare Standard Operating Procedures for all departments. To perform product quality review. Follow quality assurance systems as per cGMP guidelines.
- To follow system for releasing or rejecting of all APIs. To perform validation, calibration, qualification and line clearance.
- To prepare product labels and establishing a system to control issuance of labels.
- To ensure that all manufacturing operations, documentation & records comply with ICH Q7 system. To provide document to support vendor questionnaire received from customers.
- To perform and support all RA and QA related activities.
- To prepare/compile documents for preparation of open/applicant part DMF and to provide it to customers of various region. To provide information/data/documents for any query related to open part DMF.
- Submission of DMF to regulstory agency/agent. To collect data and documents for to prepare DMF in eCTD format and to prepare DMF for various region as per region specific guideline.
- To prepare and submit annual updates in due time.
- To track updation in various regulatory guidelines and pharmacopoeial monographs..
- Extensive experience in the pharmaceutical industry with a strong understanding of drug regulatory requirements and processes.

**Role**:Regulatory Affairs Compliance

**Salary**: ₹20,000.00 - ₹30,000.00 per month

**Benefits**:

- Flexible schedule
- Health insurance

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (required)

Ability to Commute:

- Mumbai, Maharashtra (required)

Ability to Relocate:

- Mumbai, Maharashtra: Relocate before starting work (required)

**Speak with the employer**
+91 9509628515

  • Marketing Executive- Reputed Pharmaceutical API Industry- Mumbai, Maharashtra, India

    19 hours ago

    Navi Mumbai, India Seven Consultancy Full time

    JOB DETAILS 1) Support Manager – Business Development in API Marketing efforts with Indian domestic market & Regulated market customers in India.2) Should be able to handle communication independently with customers & satisfy their requirements by co-ordinating with Plant,QA and R&D. 3) Good Communication skills, both verbal & written. 4) Previous...

  • Executive- QA

    1 week ago

    Mumbai, Maharashtra, India High Career Full time

    Roles & Reasponsiblities: This role will be responsible for - Handling vendor approval requests - filling forms, Questionnaires, sharing FAQ, documents etc. - Handling regulatory requests / queries from customers. - Sending notification to customers, answering queries, and maintaining data base - Comparing COA, Specification, test methods and providing...

  • Executive- Ra Gdd

    2 weeks ago

    Mumbai, India Novartis Full time

    1,800+ associates. 85+ countries. 1 goal. At Novartis, we are dedicated to discovering and developing new treatments for diseases including cancer, heart disease, and neurological conditions—and delivering them at a scale to reach as many patients as possible. Novartis has a unique and promising portfolio with approximately 70 projects as potential NMEs in...

  • Manager- Biologics RA-CMC

    1 week ago

    Mumbai, Maharashtra, India USV Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    USV, a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India.Explore us at Function: BiologicsPosition: Deputy Manager/Manager - Regulatory Affairs-CMCJob Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd...

  • DGM-API Sales

    7 days ago

    Mumbai, India Antal International Full time

    To strategically lead and grow the organization's Active Pharmaceutical Ingredients (API) division by driving revenue, expanding market presence, and ensuring operational excellence. This includes identifying emerging opportunities, fostering innovation, and maintaining compliance with global regulatory standards.Key Responsibilities:Drive sales targets and...

  • DGM-API Sales

    5 days ago

    Mumbai, India Antal International Full time

    To strategically lead and grow the organization's Active Pharmaceutical Ingredients (API) division by driving revenue, expanding market presence, and ensuring operational excellence. This includes identifying emerging opportunities, fostering innovation, and maintaining compliance with global regulatory standards.Key Responsibilities:Drive sales targets and...

  • DGM-API Sales

    5 days ago

    Mumbai, India Antal International Full time

    To strategically lead and grow the organization's Active Pharmaceutical Ingredients (API) division by driving revenue, expanding market presence, and ensuring operational excellence. This includes identifying emerging opportunities, fostering innovation, and maintaining compliance with global regulatory standards.Key Responsibilities:Drive sales targets and...

  • DGM-API Sales

    6 days ago

    Mumbai, India Antal International Full time

    To strategically lead and grow the organization's Active Pharmaceutical Ingredients (API) division by driving revenue, expanding market presence, and ensuring operational excellence. This includes identifying emerging opportunities, fostering innovation, and maintaining compliance with global regulatory standards.Key Responsibilities:Drive sales targets and...

  • DGM-API Sales

    6 days ago

    Mumbai, India Antal International Full time

    To strategically lead and grow the organization's Active Pharmaceutical Ingredients (API) division by driving revenue, expanding market presence, and ensuring operational excellence. This includes identifying emerging opportunities, fostering innovation, and maintaining compliance with global regulatory standards.Key Responsibilities:Drive sales targets and...

  • DGM-API Sales

    6 days ago

    mumbai, India Antal International Full time

    To strategically lead and grow the organization's Active Pharmaceutical Ingredients (API) division by driving revenue, expanding market presence, and ensuring operational excellence. This includes identifying emerging opportunities, fostering innovation, and maintaining compliance with global regulatory standards.Key Responsibilities:Drive sales targets and...