Executive Documentation, Kandivali, R&d, Vantage
7 days ago
Date:
Jul 5, 2023
Location:
Kandivali, India
Company:
ACG
- Group Company
-
ACG Capsules - Primary Responsibilities
- Documentation is a systematic procedure of preparation, checking, verifying, issuing, store and reviewing of any documents.
- The basic rules in any good manufacturing practice (GMP)regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records.
- Documentation helps to build up a detailed picture of what an activity has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future.
- Effective documentation enhances the visibility of the quality assurance system.
- Defines specifications and procedures for all materials and methods of manufacture and control.
- Good documentation constitutes an essential part of the quality assurance system.
- Clearly written procedures prevent errors resulting from spoken communication, and clear documentation permits tracing of activities performed.
- Documents must be designed, prepared, reviewed, and distributed with care.
- Documents must be approved, signed, and dated by the appropriate competent and authorized persons.
- b. Maintain record of different internal and external customer.
- c. Support internal and group company trials for customer support.
- Key Result Areas
- Defines specifications and procedures for all materials and methods of manufacture and control.
- Ensures all personnel know what to do and when to do it.
- Ensure that authorized persons have all the information necessary for release of product.
- Ensures documented evidence, traceability, provides records and audit trail for investigation.
- Ensures availability of data for validation, review, and statistical analysis.
- Key Interfaces 1. Internal
- b. Export sales team
- c. QA
- d. service engineers.
- e. Operation
- f. Purchase
- 2. External
- b. Pharmaceutical formulation R & D/ Pharmaceutical companies
- c. CRO- formulation research
-
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