HomeProductionAssistant Manager CQA | Bliss GVS Pharma | Mumbai

Assistant Manager CQA | Bliss GVS Pharma | Mumbai

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Bliss GVS is a fast-growing Pharmaceutical Company with a proven track record of developing, manufacturing, and marketing high-quality pharmaceutical formulations at affordable prices for the global market. We are a public limited company listed on India’s National Stock Exchange and Bombay Stock Exchange with more than three decades of industry expertise.

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We are among the world leaders in Suppositories and Pessaries dosage forms with one of the largest portfolios in this segment. Over the last decade, we have acquired definitive know-how in other dosage forms & therapeutic segments, which is exemplified by our ever-expanding product offering across more than sixty countries.

With the significant expansion in R & D, Manufacturing & Marketing capabilities, we are poised for an accelerated rate of growth which makes for very exciting times at Bliss GVS.

Position: Assistant Manager CQA

Location: Mumbai, Maharashtra, India

Job Description:

Roles and Responsibilities

  • Exposure to the overall quality system with QMS, instrument /Equipment Qualification, Process Validation, cleaning validation, computer system validation & documentation.
  • Expert in requirements of Analytical method validation and verification.
  • Implementation of Systems and SOPs in R&D,
  • Review of R&D documentation such as PDR, Partial Method validations, stability data, etc.
  • Review of cleaning validation policy & ensure its implementation at all plants.
  • To coordinate with various department Heads in plants for SOP review and ensure it implementation.
  • Responsible for review of various technical agreement
  • To ensure the awareness of analytical requirements are evaluated and updated through periodic training and audits.
  • To ensure market complaints are handled as per the SOP and proper investigation is performed with appropriate measures to prevent reoccurrence.
  • Good exposure to review change control, failure investigation, and CAPA.

Desired Candidate Profile:

  • Good communicator and motivator
  • Good analytical skills, problem-solving & decision-making
  • A proactive approach to problem-solving, and relish the challenge of working in a fast-moving company startup environment, as part of a highly interdisciplinary team.
  • Should have knowledge of International & National regulatory guidelines regarding drugs
  • Should have a fair knowledge of all sort of validation cleaning processes / Process / analytical methods / Computer system / Equipment and systems.
  • Must have first-line exposure towards all the major regulatory audits such as USFDA, UKMHRA, EU GMP, PICs, etc.
  • Should have a fair knowledge of handling software’s used in the Pharma industry, such as SAP, LIMS, other QMS software’s.
  • Proficient in MS-Office and Internet
  • Should have worked in Plant Quality function or R&D for at least 5 years

Qualification: MSC/B Pharm/M Pharm

Experience: Minimum of 10 years of experience in the relevant field.

Salary: Negotiable

Contact Details:

antara.sawant@blissgvs.com, hr.careers@blissgvs.com

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