Asst. QA Manager

https://bit.ly/QAMngerMedipol - Fill this Google form

Duties and responsibilities

The role would encompass a variety of responsibilities, including and not necessarily limited to the following points:

• Oversee and maintain comprehensive QA documentation (SMF, QMS, SOPs, PVPR, COPP, etc.) as per regulatory standards.
• Interpret and implement pharmacopeia requirements (IP, BP, USP, etc.) for establishing and updating procedures in the production of allopathic medicines.
• Lead process validation, equipment qualification, water system validation, and ensure meticulous documentation for all QA activities.
• Manage and resolve OOS, change control, CAPA, deviation, in-process control, and maintain the Master Formulation Record.
• Prepare the facility for, and confidently face, inspections by FDCA, WHO, MNC, and third-party authorities; ensure successful audit closures.
• Oversee and review stability studies for both existing and new products.
• Ensure compliance with national and international guidelines, maintaining a state of audit readiness at all times.
• Utilize basic computer systems for QA documentation and reporting.
• Lead and mentor the QA team, fostering a disciplined, compliant, and positive work environment.
• Demonstrate a hands-on approach, being flexible and available for extended hours as required.

Key Requirements:

In order to perform your role well, the following qualities will be required:

• B.Sc., M.Sc., B.Pharm, M.Pharm, or PhD

  in Pharmaceutical Sciences or related fields will be preferred.

• Minimum 5 years experience

  in a pharmaceutical field (tablets, capsules, dry syrup, liquid oral, external ointment), with

  at least 3 years as QA Manager

  .
• Profound knowledge of

  QA documentation

  as per Drugs and Cosmetics Act, New Schedule M, and WHO guidelines.
• Strong expertise in

  manufacturing process validation, equipment qualification, water system validation, OOS, change control, CAPA, deviation, in-process control, and stability studies

  .
• Ability to

  interpret pharmacopeial monographs

  and translate them into actionable procedures.
• Demonstrated capacity to

  handle regulatory inspections

  and ensure compliance.

• Excellent team handling skills

  , with a disciplined and compliant attitude.

• Strong character

  , adaptable, and committed to organizational goals.

Perks and Benefits:-

Duty timing : 8.30 to 7.15 ( Lunch Time 1.00pm to 1.30pm.)

1. Personal Mobile phone not allowed inside factory premises.

2. Bed (without Bedding) in a Sharing Airconditioned accommodation is available within factory compound (Available to nondrinker / nonsmoker only)

3. Canteen facility on To pay basis available to associates living inside factory compound.

4. Non resident candidate living in near vicinity to the factory premises will be preferred.

5. Candidate willing to remain associated/stable for a minimum period of 3 year need only to apply.

Reporting time to Duty : 15 Min before the duty start time