Unison Pharmaceuticals; Manufacturing IPQA In Quality Assurance
Unison Pharmaceuticals urgently seeks a talented QMS professional for our Quality Assurance team. Apply now to become a part of our team.
Qualification: B.Pharm, M.Pharm, B.Sc, MS/M.Sc
Experience: 03-08+years
Department: QMS – QA
Role: Sr. Officer/Executive/Sr. Executive
Job Location: Ahmedabad
Roles and Responsibilities
- Responsible for preparation, review, and approval of various QMS SOP with respect to CAPA, CCN, Deviation, Market complaint, and QRM.
- To prepare and review the quarterly trend of the various QMS.
- To be part of various investigations triggered by the deviation, OOS, OOT, or market complaint. Responsible for preparation, review, and approval of various QMS SOP with respect to CAPA, CCN, Deviation, Market complaint, and QRM.
- To be part of the periodic qualification of the software.
- Knowledge of various guidance I.E. EU Annex 11, CFR Part 11, GAMP 5
Perks & Benefits
- Dynamic work environment
- Career development opportunities
- Work-life balance
- Free transportation
- Free insurance coverage for self, spouse, and kids
- Range of learning opportunities to help employees grow and thrive
If you are passionate about working in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position.
May Apply to [email protected]
Opening For Manufacturing IPQA In Quality Assurance
A fast-growing global company, following vacancies for the position of Sr. Officer / Executive
Key Accountabilities/ Responsibilities
1. IPQA Manufacturing
- Permit line clearance by reviewing equipment cleaning, area cleaning, temperature, RH, preventive maintenance status, calibration validity, logbook review, BMR review upto last stage, presence of any remnants from the previous product, tool parts, nut bolts, gasket, differential pressure etc.
- Perform In-process quality-checking activities like; Compression, Coating, Capsule filling, and Inspection.
- Collect samples for QC analysis according to SOP at different stages like Granulation, Compression, Coating, and Capsule filling.
2. BMR Preparation and revision
- Collect MFC from Doc Cell and prepare a draft copy of BMR according to batch size, lot size, and area details provided by the production department.
- Send the draft BMR to the concerned departments for review.
- After approval of CCN and compliance of review comments in BMR, send the final copy for approval and authorization.
- Post completion of exhibit/validation batches, revision of BMR based on the recommendation of validation protocol report.
3. Validation / Exhibit batch
- Collect samples as per protocol at different stages; Granulation, Compression, Capsule filling, and Coating.
- Send the collected samples to the QC department.
4. Hold time study sampling
- Collect samples at each stage of processing for all new molecules.
Send the samples to the QC department based on the hold time study protocol. - Candidates should also have sound knowledge of cGMP documentation and must be familiar with cGMP requirements.
Interested candidates may also email their resumes to [email protected]
