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CQA - Executive/Sr. Executive
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#800126
Remote / WFH
ERIS Lifesciences Ltd
Job Description
External Manufacturing -LL/P2P CQA
1. Review and approve artworks of products as per Drugs and Cosmetics Act, Cosmetic Rules,
FSSAI, Legal Metrology rules etc and to ensure regulatory compliances.
2. Management of testing of finished product samples at outside laboratory and tracking status of
testing at lab.
3. Management of master database of manufacturing site, new product documents, artwork, quality
agreements specification/STP etc.
4. To work to build a positive image with manufacturing sites management.
5. To plan day to day activity for visit site for quality oversight - cause audit for investigation of
deviation, Incident, market complaint, OOS Investigation, witness analysis, site audits, CAPA
Verification and any other assigned job.
6. Ensure Good Manufacturing Practice and Compliances at third party manufacturing site through
quality oversight.
7. To conduct site audit as per schedule - Audit of sites for new product introduction, site transfer
product etc. Preparation of audit report and submit to site with recommendation and conclusion.
8. To verify compliance to the audit observation and CAPA execution and effectiveness check of
CAPA.
9. Perform periodic site visit to thoroughly review executed batch records and analytical records of
products and report alerts for critical quality events/issues to CQA Leads.
10.To support in trouble shooting during analysis of samples at outside laboratory.
11.To review analytical raw data of batches sent for testing at outside approved labs and ensure testing
is performed as per standard testing procedures.
12.Perform new product evaluation at existing approved manufacturing site. Review of product
document, raw data as per product approval SOP.
13.To review Annual product quality review data of batches manufactured at contract manufacturing
site and provide recommendation and tracking/execution of recommendation.
14.To ensure stability study sample are withdrawn for validation and annual batches by third party manufacturer.
15.Tracking of pharmacopoeia update and ensure compliance of finished product with respect to latest
version of pharmacopoeia.
16.To support/participate in corporate quality initiatives, training and workshops.
17.To review finished product COA/COC from manufacturing site and batch release.
Key Skill:
Candidates having exposure in sterile manufacturing is preferred.
Candidate should have worked in Quality assurance and have worked on shop floor in
formulation unit and have knowledge of QC and QMS tools used for investigation of deviation,
incidents, OOS, Market complaint etc.
Candidate should have knowledge of schedule M requirement and other regulatory requirements
1. Review and approve artworks of products as per Drugs and Cosmetics Act, Cosmetic Rules,
FSSAI, Legal Metrology rules etc and to ensure regulatory compliances.
2. Management of testing of finished product samples at outside laboratory and tracking status of
testing at lab.
3. Management of master database of manufacturing site, new product documents, artwork, quality
agreements specification/STP etc.
4. To work to build a positive image with manufacturing sites management.
5. To plan day to day activity for visit site for quality oversight - cause audit for investigation of
deviation, Incident, market complaint, OOS Investigation, witness analysis, site audits, CAPA
Verification and any other assigned job.
6. Ensure Good Manufacturing Practice and Compliances at third party manufacturing site through
quality oversight.
7. To conduct site audit as per schedule - Audit of sites for new product introduction, site transfer
product etc. Preparation of audit report and submit to site with recommendation and conclusion.
8. To verify compliance to the audit observation and CAPA execution and effectiveness check of
CAPA.
9. Perform periodic site visit to thoroughly review executed batch records and analytical records of
products and report alerts for critical quality events/issues to CQA Leads.
10.To support in trouble shooting during analysis of samples at outside laboratory.
11.To review analytical raw data of batches sent for testing at outside approved labs and ensure testing
is performed as per standard testing procedures.
12.Perform new product evaluation at existing approved manufacturing site. Review of product
document, raw data as per product approval SOP.
13.To review Annual product quality review data of batches manufactured at contract manufacturing
site and provide recommendation and tracking/execution of recommendation.
14.To ensure stability study sample are withdrawn for validation and annual batches by third party manufacturer.
15.Tracking of pharmacopoeia update and ensure compliance of finished product with respect to latest
version of pharmacopoeia.
16.To support/participate in corporate quality initiatives, training and workshops.
17.To review finished product COA/COC from manufacturing site and batch release.
Key Skill:
Candidates having exposure in sterile manufacturing is preferred.
Candidate should have worked in Quality assurance and have worked on shop floor in
formulation unit and have knowledge of QC and QMS tools used for investigation of deviation,
incidents, OOS, Market complaint etc.
Candidate should have knowledge of schedule M requirement and other regulatory requirements
